Trial Outcomes & Findings for HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients (NCT NCT03500315)
NCT ID: NCT03500315
Last Updated: 2026-09-01
Results Overview
Time to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
207 participants
Primary outcome timeframe
From date of transplant through administrative censorship at study completion, up to 4 years
Results posted on
2026-09-01
Participant Flow
510 participants agreed to participate. Per protocol, particiants were not considered enrolled (n=207) until transplant. For the observational arm, only time to graft failure and acute rejection were collected, obtained from Scientific Registry of Transplant Recipients (September 2023 data export). Other outcome data were not collected on observational arm.
Participant milestones
| Measure |
Experimental: HIV D+/R+
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
99
|
9
|
|
Overall Study
COMPLETED
|
82
|
84
|
6
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
3
|
Reasons for withdrawal
| Measure |
Experimental: HIV D+/R+
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Overall Study
Death
|
12
|
11
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
0
|
|
Overall Study
Transplant post graft loss while enrolled in the study
|
0
|
1
|
0
|
Baseline Characteristics
HOPE in Action Prospective Multicenter, Clinical Trial of Deceased HIVD+ Kidney Transplants for HIV+ Recipients
Baseline characteristics by cohort
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
n=9 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
Total
n=207 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
20 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
34 Participants
n=49 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=14 Participants
|
79 Participants
n=36 Participants
|
7 Participants
n=324 Participants
|
173 Participants
n=49 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=14 Participants
|
20 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
34 Participants
n=49 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=14 Participants
|
19 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
37 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=14 Participants
|
80 Participants
n=36 Participants
|
7 Participants
n=324 Participants
|
170 Participants
n=49 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
6 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Black or African American
|
75 Participants
n=14 Participants
|
69 Participants
n=36 Participants
|
9 Participants
n=324 Participants
|
153 Participants
n=49 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
1 Participants
n=49 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=14 Participants
|
9 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
13 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=14 Participants
|
15 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
25 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=14 Participants
|
84 Participants
n=36 Participants
|
9 Participants
n=324 Participants
|
182 Participants
n=49 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
0 Participants
n=49 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=14 Participants
|
99 Participants
n=36 Participants
|
9 Participants
n=324 Participants
|
207 Participants
n=49 Participants
|
PRIMARY outcome
Timeframe: From date of transplant through administrative censorship at study completion, up to 4 yearsTime to first of any of the following events: death or graft failure or serious adverse event (SAE) or HIV breakthrough or HIV virologic failure or opportunistic infection
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Composite Event, Time to First Death or Graft Failure or Serious Adverse Event (SAE) or HIV Breakthrough or Opportunistic Infection
|
0.36 Years
Interval 0.05 to 2.08
|
0.34 Years
Interval 0.05 to 2.02
|
—
|
SECONDARY outcome
Timeframe: At 1 and 2 years post-consent, prior to transplantPopulation: Since fewer than 50% of the consented participants experienced the outcome, median time to event could not be estimated using a survival framework. We here alternatively reported the cumulative incidence at 1 year and 2 years after consenting on the study. This analysis included all participants who provided consent to the study, regarless of whether they underwent a transplant by study completion.
Cumulative incidence of mortality while enrolled before transplant
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=515 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Pre-transplant Mortality
Year 1
|
2.7 Percentage of participants
Interval 1.4 to 4.9
|
—
|
—
|
|
Pre-transplant Mortality
Year 2
|
7.8 Percentage of participants
Interval 5.0 to 12.2
|
—
|
—
|
SECONDARY outcome
Timeframe: At 1 and 3 years post transplantPopulation: Since fewer than 50% of the transplanted participants experienced the outcome, median time to event could not be estimated using a survival framework. We here alternatively reported the cumulative incidence at 1 year and 3 years. Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Cumulative incidence of graft failure
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
n=9 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Failure
Year 3
|
15.7 Percentage of participants
Interval 8.8 to 27.1
|
19.0 Percentage of participants
Interval 12.2 to 29.0
|
0 Percentage of participants
Not estimable due to insufficient number of participants with events
|
|
Graft Failure
Year 1
|
7.1 Percentage of participants
Interval 3.4 to 14.3
|
10.2 Percentage of participants
Interval 5.6 to 18.1
|
0 Percentage of participants
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From date of transplant through graft failure or administrative censorship at study completion, up to year 4Count of post-transplant serious adverse events per person-year as assessed by Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Rate of Serious Adverse Events
|
0.88 serious adverse events per person-years
Interval 0.76 to 1.0
|
0.98 serious adverse events per person-years
Interval 0.86 to 1.12
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-transplantPercentage of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (\>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
n=9 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
6-month Acute Rejection
|
8.1 Percentage of participants
|
12.1 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant to end of year 1Percentage of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (\>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
n=9 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
1-year Acute Rejection
|
13.1 Percentage of participants
|
20.2 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At 1 and 3 years post transplantCumulative incidence of acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (\>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3). Outcome data of the observational group were obtained from the Scientific Registry of Transplant Recipients (September 2023 data export).
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
n=9 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of Graft Rejection
Year 1
|
13.3 percentage of participants
Interval 8.0 to 21.8
|
21.4 percentage of participants
Interval 14.4 to 31.1
|
0 percentage of participants
Not estimable due to insufficient number of participants with events
|
|
Incidence of Graft Rejection
Year 3
|
20.5 percentage of participants
Interval 13.2 to 31.2
|
23.9 percentage of participants
Interval 16.4 to 34.0
|
0 percentage of participants
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: At 3 months post-transplantPopulation: Participants must be alive, with or without a functioning allograft and had eGFR data collected at 3 months to be included in the analysis. A total of 2 HIV D+/R+ and 2 HIV D-/R+ participants were excluded due to death, missing eGFR data, or lack of study follow-up at 3 months
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \< 60 mL/min/1.73 m2
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=97 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=97 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
|
71 Participants
|
69 Participants
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-transplantPopulation: Participants must be alive, with or without a functioning allograft and had eGFR data collected at 6 months to be included in the analysis. A total of 5 HIV D+/R+ and 7 HIV D-/R+ participants were excluded due to death, missing eGFR data, or lack of study follow-up at 6 months.
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<60 mL/min/1.73 m\^2
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=94 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=92 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
|
69 Participants
|
63 Participants
|
—
|
SECONDARY outcome
Timeframe: 9 months post-transplantPopulation: Participants must be alive, with or without a functioning allograft and had eGFR data collected at 9 months to be included in the analysis. A total of 10 HIV D+/R+ and 14 HIV D-/R+ participants were excluded due to death, missing eGFR data, or lack of study follow-up at 9 months.
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<60 mL/min/1.73 m\^2
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=89 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=85 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
|
62 Participants
|
67 Participants
|
—
|
SECONDARY outcome
Timeframe: At year 1 post-transplantPopulation: Participants must be alive, with or without a functioning allograft and had eGFR data collected at 1 year to be included in the analysis. A total of 8 HIV D+/R+ and 10 HIV D-/R+ participants were excluded due to death, missing eGFR data, or lack of study follow-up at 1 year.
Number of transplant recipients with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<60 mL/min/1.73 m\^2
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=91 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=89 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
|
66 Participants
|
64 Participants
|
—
|
SECONDARY outcome
Timeframe: At year 2 post-transplantPopulation: Participants must be alive, with or without a functioning allograft and had eGFR data collected at 2 years to be included in the analysis. A total of 44 HIV D+/R+ and 52 HIV D-/R+ participants were excluded due to death, missing eGFR data, or lack of study follow-up at 2 years.
Percentage of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<60 mL/min/1.73 m\^2
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=55 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=47 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function Number of Participants With eGRF<60 mL/Min/1.73 m^2
|
42 Participants
|
35 Participants
|
—
|
SECONDARY outcome
Timeframe: At year 3 post-transplantPopulation: Participants must be alive, with or without a functioning allograft and had eGFR data collected at 3 years to be included in the analysis. A total of 73 HIV D+/R+ and 76 HIV D-/R+ participants were excluded due to death, missing eGFR data, or lack of study follow-up at 3 years.
Percentage of participants with glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<60 mL/min/1.73 m\^2
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=26 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=23 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function - Number of Participants With eGFR <60 mL/Min/1.73 m^2
|
19 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months post-transplantPopulation: Include participants who were alive with or without a functioning allograft and had eGFR data collected at Month 3
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=97 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=97 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function -Mean eGFR
|
50.9 mL/min/1.73 m^2
Standard Deviation 17.9
|
48.9 mL/min/1.73 m^2
Standard Deviation 20.2
|
—
|
SECONDARY outcome
Timeframe: 6 months post-transplantPopulation: Include participants who were alive with or without a functioning allograft and had eGFR data collected at Month 6
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=94 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=92 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function-mean eGFR
|
50.8 mL/min/1.73 m^2
Standard Deviation 17.8
|
52.0 mL/min/1.73 m^2
Standard Deviation 20.3
|
—
|
SECONDARY outcome
Timeframe: 9 months post-transplantPopulation: Include participants who were alive with or without a functioning allograft and had eGFR data collected at Month 9
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=89 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=85 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function-mean eGFR
|
51.4 mL/min/1.73 m^2
Standard Deviation 18.6
|
47.7 mL/min/1.73 m^2
Standard Deviation 19.4
|
—
|
SECONDARY outcome
Timeframe: 1 year post-transplantPopulation: Include participants who were alive with or without a functioning allograft and had eGFR data collected at Year 1
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=91 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=89 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function-mean eGFR
|
50.9 mL/min/1.73 m^2
Standard Deviation 20.5
|
50.5 mL/min/1.73 m^2
Standard Deviation 22.7
|
—
|
SECONDARY outcome
Timeframe: 2 years post-transplantPopulation: Include participants who were alive with or without a functioning allograft and had eGFR data collected at Year 2
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=55 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=47 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function-mean eGFR
|
50.8 mL/min/1.73 m^2
Standard Deviation 20.4
|
50.6 mL/min/1.73 m^2
Standard Deviation 20.3
|
—
|
SECONDARY outcome
Timeframe: 3 years post-transplantPopulation: Include participants who were alive with or without a functioning allograft and had eGFR data collected at Year 3
Mean calculated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=26 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=23 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function-mean eGFR
|
45.3 mL/min/1.73 m^2
Standard Deviation 25.0
|
51.3 mL/min/1.73 m^2
Standard Deviation 23.2
|
—
|
SECONDARY outcome
Timeframe: From date of transplant to end of follow-up, up to 4 yearsPopulation: Include participants who were alive with or without a functioning allograft and had eGFR starting at 3 months post-transplant, when most recipients have fully functioning transplant kidneys
The slope of glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over time (longitudinal analysis)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=98 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=97 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Graft Function - Slope eGFR
|
-0.12 ml/min per 1.73 m^2 per year
Interval -1.13 to 1.9
|
-.47 ml/min per 1.73 m^2 per year
Interval -1.46 to 0.52
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participants with both donor and recipient APOL1 data were included.
Percentage of transplant recipients with at least 1 apolipoprotein L1 (APOL1) risk variant in donor and recipient
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=34 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=10 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Donor and Recipient Apolipoprotein L1 (APOL1)
|
73.5 Percentage of participants
|
60.0 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of follow-up, up to 4 yearsPopulation: At each timepoint, only participants who have had the tests were included in the analysis.
Trajectory of recipient plasma HIV RNA over time. Analysis of repeated measures of plasma HIV RNA (longitudinal model). Below 50 copies/mL was used as the threshold of undetectable HIV RNA.
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Participants With Undetectable HIV RNA
Week 208
|
3 Participants
|
5 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Day 0
|
95 Participants
|
91 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 2
|
83 Participants
|
71 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 3
|
81 Participants
|
78 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 4
|
92 Participants
|
91 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 8
|
90 Participants
|
87 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 13
|
93 Participants
|
90 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 26
|
85 Participants
|
85 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 39
|
79 Participants
|
73 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 104
|
42 Participants
|
39 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 130
|
26 Participants
|
32 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 156
|
17 Participants
|
21 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 182
|
7 Participants
|
13 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 1
|
79 Participants
|
74 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 52
|
81 Participants
|
77 Participants
|
—
|
|
Participants With Undetectable HIV RNA
Week 78
|
70 Participants
|
51 Participants
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of follow up, up to 4 yearsPopulation: For each timepoint, only participants whose CD4 count were available were included in the calculation.
Analysis of repeated measures of Cluster of Differentiation 4 (CD4) count (longitudinal model)
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Day 0
|
511 Cells/μL
Interval 375.0 to 652.0
|
492 Cells/μL
Interval 362.0 to 686.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 1
|
183 Cells/μL
Interval 16.0 to 464.0
|
149.5 Cells/μL
Interval 13.0 to 333.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 2
|
399 Cells/μL
Interval 72.0 to 609.0
|
213.5 Cells/μL
Interval 62.0 to 394.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 3
|
271 Cells/μL
Interval 75.0 to 603.0
|
352 Cells/μL
Interval 100.0 to 442.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 4
|
217 Cells/μL
Interval 82.0 to 510.0
|
168 Cells/μL
Interval 84.0 to 380.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 8
|
213 Cells/μL
Interval 93.6 to 488.5
|
231 Cells/μL
Interval 106.0 to 385.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 13
|
230.5 Cells/μL
Interval 124.0 to 446.5
|
184 Cells/μL
Interval 101.0 to 361.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 26
|
269 Cells/μL
Interval 176.0 to 457.0
|
227 Cells/μL
Interval 131.0 to 375.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 39
|
295.9 Cells/μL
Interval 152.5 to 471.5
|
255 Cells/μL
Interval 159.0 to 405.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 52
|
324 Cells/μL
Interval 195.5 to 476.0
|
250 Cells/μL
Interval 165.0 to 397.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 78
|
311 Cells/μL
Interval 204.0 to 501.0
|
245 Cells/μL
Interval 173.0 to 386.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 104
|
370 Cells/μL
Interval 229.0 to 569.5
|
245 Cells/μL
Interval 173.0 to 386.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 130
|
332 Cells/μL
Interval 236.0 to 424.0
|
277.5 Cells/μL
Interval 179.0 to 502.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 156
|
369.5 Cells/μL
Interval 284.0 to 468.0
|
326 Cells/μL
Interval 177.0 to 532.0
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 182
|
501.5 Cells/μL
Interval 305.5 to 589.0
|
465.5 Cells/μL
Interval 222.0 to 653.5
|
—
|
|
Trajectory of Recipient Cluster of Differentiation (CD4) Count Over Time
Week 208
|
348 Cells/μL
Interval 335.0 to 430.0
|
541 Cells/μL
Interval 318.0 to 560.0
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of follow-up, up to 4 yearsMeasured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads \>200 copies/mL or one HIV viral load \>1000 copies/mL after a period of virologic control post-transplant
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of Antiretroviral Resistance
|
0 Number of events
|
0 Number of events
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of follow-up, up to 4 yearsMeasured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads \>200 copies/mL or one HIV viral load \>1000 copies/mL after a period of virologic control post-transplant
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of X4 Tropic Virus
|
0 Number of events
|
0 Number of events
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of follow-up, up to 4 yearsCumulative incidence of opportunistic infections
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of Opportunistic Infection
|
47.0 Number of cases per 1000 person years
Interval 26.0 to 84.9
|
35.4 Number of cases per 1000 person years
Interval 17.7 to 70.7
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through year 1Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of Surgical Complications
|
13 number of events
|
18 number of events
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through year 1Number of vascular complications within 1 year of transplant
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of Vascular Complications
|
6 Number of events
|
7 Number of events
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of follow-up, up to 4 yearsNumber of malignancies as determined by local pathology
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Incidence of Viral-related Malignancies
|
1 Number of events
|
3 Number of events
|
—
|
SECONDARY outcome
Timeframe: From date of transplant through end of year 1Population: Participants with donor-specific HLA data at both day 0 and at 1 year are included in the analysis
Participants must have donor-specific HLA data at both day 0 and at 1 year to be included in the analysis. A total of 32 HIV D+/R+ and 40 HIV D-/R+ participants were excluded due to missing donor-specific data at either day 0 or 1 year.
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=67 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=59 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Participants With Formation of de Novo Donor-specific Human Leukocyte Antigen(HLA) Antibodies
|
9 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: At 6 months, 1 and 3 years post-transplantCumulative incidence of the composite event, which is defined as the occurrence of first event of any of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness
Outcome measures
| Measure |
Experimental: HIV D+/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 Participants
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
No Intervention: HIV D-/R+ (Observational)
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor and randomized to observational group
|
|---|---|---|---|
|
Composite Event, Cumulative Incidence
Month 6
|
13.3 percentage of participants
Interval 7.9 to 21.5
|
19.4 percentage of participants
Interval 12.8 to 28.7
|
—
|
|
Composite Event, Cumulative Incidence
Year 3
|
44.5 percentage of participants
Interval 33.4 to 57.5
|
41.6 percentage of participants
Interval 31.8 to 52.9
|
—
|
|
Composite Event, Cumulative Incidence
Year 1
|
24.2 percentage of participants
Interval 17.0 to 34.0
|
30.6 percentage of participants
Interval 22.5 to 40.8
|
—
|
Adverse Events
Experimental: HIV D+/R+
Serious events: 74 serious events
Other events: 11 other events
Deaths: 12 deaths
No Intervention: HIV D-/R+
Serious events: 76 serious events
Other events: 4 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Experimental: HIV D+/R+
n=99 participants at risk
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 participants at risk
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Cardiac disorders
Acute myocardial infraction
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Cardiac disorders
Pericarditis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Endocrine disorders
Diabetic ketoacidosis
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Endocrine disorders
Hyperglycemia
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Endocrine disorders
Diabetes mellitus
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Aphthous ulcers
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Fistula of small intestine
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Gastritis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Oesophageal carcinoma
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Oral candidiasis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Pancreatitis necrotizing
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Postoperative ileus
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
General disorders
Chest pain
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
General disorders
Death
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
General disorders
Pyrexia
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
General disorders
Ulcer (Right lower extremity ulceration)
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Hepatobiliary disorders
Hepatic failure
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Immune system disorders
Kidney transplant rejection
|
9.1%
9/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
9.1%
9/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Immune system disorders
Transplant rejection
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
7.1%
7/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Bacteremia
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Bacterial sepsis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Clostridium difficile infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
COVID-19
|
38.4%
38/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
30.3%
30/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Cryptosporidiosis infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
CMV (Cytomegalovirus) viremia
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Device related infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Enterococcal bacteremia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Histoplasmosis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
HIV viremia (breakthrough)
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Influenza
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Kaposi's sarcoma
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Monkeypox
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Esophageal candidiasis
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Parvovirus B19 infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Pneumonia pseudomonal
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Pseudomonas infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Pyelonephritis
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Rotavirus infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Sepsis
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Shigella infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Tooth infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Urinary tract infection
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Urinary tract obstruction
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Urosepsis
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Varicella zoster virus infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Delayed graft function
|
6.1%
6/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Graft loss
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Wound hematoma
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Injury, poisoning and procedural complications
Wound infection staphylococcal
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Investigations
Bartonella test positive
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Investigations
Blood creatinine increased
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Investigations
Drug trough level (increased tacrolimus level)
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Investigations
Hemoglobin decreased
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Investigations
Transaminases increased
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Cerebellar stroke
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Headache
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Meningitis bacterial
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Neuropathy peripheral (from diabetes)
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Spinal cord abscess
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Nervous system disorders
Syncope
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Psychiatric disorders
Anxiety
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.1%
6/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
7.1%
7/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Perinephric abscess
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Perinephric collection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Polyomavirus-associated nephropathy
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Pyelonephritis
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Renal cell carcinoma
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Renal graft infection
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Renal tubular injury
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Ureteral necrosis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Ureteral stenosis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Renal and urinary disorders
Urosepsis
|
6.1%
6/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Reproductive system and breast disorders
Pelvic hematoma
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Gastrointestinal hemorrhage
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsil cancer
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Surgical and medical procedures
Nephrostomy
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Acute myocardial infraction
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Arteriovenous fistula site complication
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Arteriovenous fistula thrombosis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
4.0%
4/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Hematoma
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Hematuria
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Hypertension
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Hypertensive crisis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Hypotension
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Ischemia
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Pelvic venous thrombosis
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Renal hematoma
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Renal vein thrombosis
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
2.0%
2/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Renovascular hypertension
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Small intestinal hemorrhage
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Vascular disorders
Syncope
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
0.00%
0/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
Other adverse events
| Measure |
Experimental: HIV D+/R+
n=99 participants at risk
HIV-infected individuals that accept an organ from an HIV-infected deceased donor
|
No Intervention: HIV D-/R+
n=99 participants at risk
HIV-infected individuals that accept an organ from an HIV-uninfected deceased donor
|
|---|---|---|
|
Infections and infestations
Cytomegalovirus infection
|
5.1%
5/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
1.0%
1/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
6.1%
6/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
3.0%
3/99 • From date of transplant through end of follow-up, up to 4 years
Adverse events were not collected for the observational group.
|
Additional Information
Christine Durand, MD
Johns Hopkins University School of Medicine
Phone: 443-803-1931
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place