Trial Outcomes & Findings for HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant (NCT NCT02902120)
NCT ID: NCT02902120
Last Updated: 2024-04-22
Results Overview
Sustained virologic response (SVR) will be assessed by measuring the quantitative HCV viral load 12 weeks after completing treatment. This will be a measure of circulating HCV virus in participants off therapy, 12 weeks after finishing treatment, to determine the durability of the response to the treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
This will be measured at post-treatment week 12 (study week 24 or week 28 for those with resistance mutations)
Results posted on
2024-04-22
Participant Flow
Participant milestones
| Measure |
Post-transplant
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Post-transplant
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant
Baseline characteristics by cohort
| Measure |
Post-transplant
n=21 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
59.65 years
STANDARD_DEVIATION 8.17 • n=99 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
|
Fibrosis Stage
Fibrosis Stage 0-1
|
12 Participants
n=99 Participants
|
|
Fibrosis Stage
Fibrosis Stage 2-3
|
9 Participants
n=99 Participants
|
|
HCV-positive donor
|
19 Participants
n=99 Participants
|
|
HCV genotype post-transplant
Genotype 1a
|
14 Participants
n=99 Participants
|
|
HCV genotype post-transplant
Genotype 1b
|
7 Participants
n=99 Participants
|
|
Median baseline HCV RNA level
|
6.24 Log international units/mL
n=99 Participants
|
|
Time from transplant
|
117 days
n=99 Participants
|
PRIMARY outcome
Timeframe: This will be measured at post-treatment week 12 (study week 24 or week 28 for those with resistance mutations)Sustained virologic response (SVR) will be assessed by measuring the quantitative HCV viral load 12 weeks after completing treatment. This will be a measure of circulating HCV virus in participants off therapy, 12 weeks after finishing treatment, to determine the durability of the response to the treatment.
Outcome measures
| Measure |
Post-transplant
n=21 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
SVR 12
Number achieved SVR12
|
19 Participants
|
|
SVR 12
Number failed treatment
|
1 Participants
|
|
SVR 12
Number missing SVR12 data
|
1 Participants
|
SECONDARY outcome
Timeframe: This will be collected at day 0, week 4, and week 12Population: This study was amended to eliminate the comparator arm and focus on clinical outcomes including SVR12. No subjects were recruited in this arm, so no data was collected or is available.
The study will involve measuring the change in T cell response by analyzing the frequency of exhaustion markers PD-1 and activation markers ICOS, CD38, CD69 at day 0, week 4, and week 12.
Outcome measures
| Measure |
Post-transplant
n=6 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
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|---|---|
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Change in T Cell Response
PD-1 day 0
|
29.15 percentage of expressing cells
Standard Deviation 15.21
|
|
Change in T Cell Response
PD-1 week 4
|
21.83 percentage of expressing cells
Standard Deviation 14.52
|
|
Change in T Cell Response
PD-1 week 12
|
20.5 percentage of expressing cells
Standard Deviation 8.91
|
|
Change in T Cell Response
ICOS day 0
|
12.73 percentage of expressing cells
Standard Deviation 7.92
|
|
Change in T Cell Response
ICOS week 4
|
6.14 percentage of expressing cells
Standard Deviation 5.65
|
|
Change in T Cell Response
ICOS week 12
|
5.03 percentage of expressing cells
Standard Deviation 2.81
|
|
Change in T Cell Response
CD38 day 0
|
10.86 percentage of expressing cells
Standard Deviation 4.81
|
|
Change in T Cell Response
CD38 week 4
|
5.97 percentage of expressing cells
Standard Deviation 4.43
|
|
Change in T Cell Response
CD38 week 12
|
6.73 percentage of expressing cells
Standard Deviation 4.48
|
|
Change in T Cell Response
CD69 day 0
|
0.98 percentage of expressing cells
Standard Deviation 0.60
|
|
Change in T Cell Response
CD69 week 4
|
0.43 percentage of expressing cells
Standard Deviation 0.26
|
|
Change in T Cell Response
CD69 week 12
|
0.75 percentage of expressing cells
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: This will be collected at day 0, week 4, and week 12Population: This study was amended to eliminate the comparator arm and focus on clinical outcomes including SVR12. No subjects were recruited in this arm, so no data was collected or is available. The frequency of CD4+ and CD8+ effector memory, naïve, central memory and terminally differentiated effector memory cell populations were compared from day 0 to week 4 on treatment.
The study will involve measuring the change in T cell immunophenotypes
Outcome measures
| Measure |
Post-transplant
n=9 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
Change in T Cell Immunophenotypes
CD4+CCR7-CD45RO+ EM day 0
|
70.64 percentage of expressing cells
Standard Deviation 17.48
|
|
Change in T Cell Immunophenotypes
CD4+CCR7-CD45RO+ EM week 4
|
65.4 percentage of expressing cells
Standard Deviation 11.17
|
|
Change in T Cell Immunophenotypes
CD4+CCR7-CD45RO+ EM week 12
|
65.1 percentage of expressing cells
Standard Deviation 13.29
|
SECONDARY outcome
Timeframe: This will be collected at day 0 and week 4Population: This study was amended to eliminate the comparator arm and focus on clinical outcomes including SVR12. No subjects were recruited in this arm, so no data was collected or is available. Analysis was done comparing IFN gamma and TNF alpha from day 0 to week 4.
The study will involve measuring interferon gamma and TNF alpha levels
Outcome measures
| Measure |
Post-transplant
n=19 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
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|---|---|
|
Quantification of Antiviral Cytokines
TNF alpha day 0
|
7.26 pg/mL
Standard Deviation 2.74
|
|
Quantification of Antiviral Cytokines
IFN gamma day 0
|
9.67 pg/mL
Standard Deviation 7.12
|
|
Quantification of Antiviral Cytokines
IFN gamma week 4
|
7.26 pg/mL
Standard Deviation 6.19
|
|
Quantification of Antiviral Cytokines
TNF alpha week 4
|
4.45 pg/mL
Standard Deviation 3.55
|
SECONDARY outcome
Timeframe: This will be measured at day 0, weeks 2, 4, 8, 12 (and 16 if resistance mutations are present)Safety will be assessed by adverse event monitoring, including routine lab work
Outcome measures
| Measure |
Post-transplant
n=21 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
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|---|---|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Any Adverse Event · Yes
|
21 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Any Adverse Event · No
|
0 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Any Serious Adverse Event · Yes
|
6 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Any Serious Adverse Event · No
|
15 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Decrease in eGFR >30% from baseline · Yes
|
4 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Decrease in eGFR >30% from baseline · No
|
17 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Elevated tacrolimus level while on treatment · Yes
|
13 Participants
|
|
Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work
Elevated tacrolimus level while on treatment · No
|
8 Participants
|
SECONDARY outcome
Timeframe: This will be measured at day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28)Clinical review using labs and the patient's chart will be performed for change in kidney graft function by change in eGFR or creatinine
Outcome measures
| Measure |
Post-transplant
n=21 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
Kidney Function
Increase in Cr >30% on treatment · yes
|
5 Participants
|
|
Kidney Function
Increase in Cr >30% on treatment · no
|
16 Participants
|
|
Kidney Function
Decrease eGFR >30% · yes
|
4 Participants
|
|
Kidney Function
Decrease eGFR >30% · no
|
17 Participants
|
SECONDARY outcome
Timeframe: This will be measured at post-treatment week 12Clinical review using labs and the patient's chart will be performed for documented episodes of kidney rejection
Outcome measures
| Measure |
Post-transplant
n=21 Participants
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
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|---|---|
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Kidney Allograft Rejection
Borderline acute cellular rejection
|
1 Participants
|
|
Kidney Allograft Rejection
Mild antibody mediated rejection
|
1 Participants
|
|
Kidney Allograft Rejection
No rejection
|
19 Participants
|
Adverse Events
Post-transplant
Serious events: 6 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Post-transplant
n=21 participants at risk
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
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|---|---|
|
Gastrointestinal disorders
Nausea, vomiting
|
14.3%
3/21 • Number of events 3 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
CMV Viremia
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Gastrointestinal disorders
Decreased appetite
|
9.5%
2/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
UTI, sepsis
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Renal and urinary disorders
acute kidney injury
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Endocrine disorders
Diabetic ketoacidosis
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
Shingles
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
URI
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
Community acquired pneumonia
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
Other adverse events
| Measure |
Post-transplant
n=21 participants at risk
This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \<50) who have had a kidney transplant using grazoprevir and elbasvir.
Post-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
|
|---|---|
|
General disorders
Fatigue
|
42.9%
9/21 • Number of events 9 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Renal and urinary disorders
Elevated tacrolimus level
|
81.0%
17/21 • Number of events 73 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Renal and urinary disorders
Elevated creatinine or AKI
|
28.6%
6/21 • Number of events 21 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Blood and lymphatic system disorders
Low platelets
|
9.5%
2/21 • Number of events 4 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Gastrointestinal disorders
Diarrhea
|
23.8%
5/21 • Number of events 5 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Gastrointestinal disorders
nausea, vomiting
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
UTI
|
19.0%
4/21 • Number of events 5 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
candida infection
|
14.3%
3/21 • Number of events 5 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
CMV viremia, syndrome
|
19.0%
4/21 • Number of events 4 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Blood and lymphatic system disorders
anemia
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
shingles
|
9.5%
2/21 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Nervous system disorders
Tremor
|
9.5%
2/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
3/21 • Number of events 3 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Investigations
Decreased Tacrolimus levels
|
90.5%
19/21 • Number of events 138 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Renal and urinary disorders
Microalbuminuria
|
14.3%
3/21 • Number of events 3 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Vascular disorders
ankle swelling
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Blood and lymphatic system disorders
Elevated WBCs
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Immune system disorders
seasonal allergies
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Immune system disorders
pruritis
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Respiratory, thoracic and mediastinal disorders
dry cough
|
14.3%
3/21 • Number of events 4 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
General disorders
decreased appetite
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Reproductive system and breast disorders
orchitis
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Immune system disorders
mild antibody mediated rejection
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Endocrine disorders
increased glucose
|
4.8%
1/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Musculoskeletal and connective tissue disorders
Groin strain or pain
|
9.5%
2/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Nervous system disorders
fall
|
9.5%
2/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Cardiac disorders
Elevated Blood Pressure
|
4.8%
1/21 • Number of events 3 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Cardiac disorders
Hypotension
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Endocrine disorders
osteoporosis
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Renal and urinary disorders
pyuria
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Endocrine disorders
cold sweats
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Nervous system disorders
neuropathy
|
9.5%
2/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
Stye
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Infections and infestations
URI, pharyngitis, rhinitis, bronchitis
|
19.0%
4/21 • Number of events 6 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Gastrointestinal disorders
indigestion, GERD
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Musculoskeletal and connective tissue disorders
muscle cramps
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Ear and labyrinth disorders
otitis media
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
9.5%
2/21 • Number of events 2 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
|
Nervous system disorders
dizziness
|
4.8%
1/21 • Number of events 1 • Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).
|
Additional Information
Lydia Tang
Institute of Human Virology, University of Maryland School of Medicine
Phone: 410-706-6567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place