Trial Outcomes & Findings for Subcutaneous Abatacept in Renal Transplant Recipients (NCT NCT05975450)
NCT ID: NCT05975450
Last Updated: 2026-04-03
Results Overview
Incidence of any malignancy, including Post-Transplant Lymphoproliferative Disorder (PTLD)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Up to 12 months post-transplantation, an average of 8 months
Results posted on
2026-04-03
Participant Flow
Participants were recruited from Emory Healthcare of Atlanta in Atlanta, Georgia, USA. Participant enrollment began August 2, 2023, and all follow-up was complete by February 14, 2025.
Participant milestones
| Measure |
Abatacept
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Abatacept
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Patient developed BK BK Polyoma Virus one week before starting the study drug
|
1
|
Baseline Characteristics
Subcutaneous Abatacept in Renal Transplant Recipients
Baseline characteristics by cohort
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsCompliance and self-administration will be measured using the abatacept administration logs and autoinjector accountability.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Who Are Compliant With Self-administration
Participants compliants with all doses
|
8 Participants
|
|
Number of Participants Who Are Compliant With Self-administration
Participants who missed one (1) dose
|
5 Participants
|
|
Number of Participants Who Are Compliant With Self-administration
Participants who missed two (2) doses
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsFor-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Who Remain Free of Biopsy-proven Acute T-cell Mediated Rejection (aTCMR) or Antibody-mediated Rejection (ABMR) as Defined by Banff Criteria at or Before 12 Months After Transplantation.
|
13 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsAssessments of serious adverse events will be completed at each study visit from the time abatacept starts through 12 months post-transplant.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Presenting Serious Adverse Events
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsAny serious infection requiring hospitalization or prolonged therapy, including but not limited to treatment ≥ 20 days, will be documented.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants With Serious Infections
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsAll subjects will be monitored for CMV infection by quantitative polymerase chain reaction (PCR) in the blood per the Emory Transplant Center standard of care protocol, CMV viremia stratified by count ≥35 but \<10,000 or ≥ 10,000.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude
≥35 but <10,000
|
1 Participants
|
|
Number of Patients With Cytomegalovirus (CMV) Viremia Stratified by the Magnitude
≥ 10,000
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsUndetected, \>0 but \< 1,000, ≥ 1,000 but \<10,000, or ≥ 10,000 - 100,000, ≥100,000 or stratified by log, which is reported as a result.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Patients With BK Viremia Stratified by the Magnitude
Undetected
|
13 Participants
|
|
Number of Patients With BK Viremia Stratified by the Magnitude
>0 but < 1,000
|
0 Participants
|
|
Number of Patients With BK Viremia Stratified by the Magnitude
≥ 1,000 but <10,000
|
1 Participants
|
|
Number of Patients With BK Viremia Stratified by the Magnitude
≥ 10,000 - 100,000
|
0 Participants
|
|
Number of Patients With BK Viremia Stratified by the Magnitude
100,000 ≥ 100,000
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsIncidence of any malignancy, including Post-Transplant Lymphoproliferative Disorder (PTLD)
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Who Develop Any Malignancy
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsDeath and/or allograft failure at or before 12 months after transplantation
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Experiencing the Composite Outcome of Death or Allograft Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsIncidence of biopsy-proven acute T-cell mediated cellular rejection (BP-aTCMR)
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants With Biopsy-proven Acute T-cell Mediated Cellular Rejection (BP-aTCMR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsThe number of participants treated for rejection with any of the following: i) corticosteroids within 12 months, ii) T-cell depleting therapy within 12 months, iii) any other treatment for rejection within 12 months of transplantation
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Treated for Rejection
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsFor-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Treated for Acute Rejection Due to Clinical Suspicion Rather Than BP-aTCMR or BP-aABMR Within 12 Months of Transplantation.
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsFor-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants With Biopsy-proven Active Antibody-mediated Rejection (BP-aABMR)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsFor-cause biopsies may be performed as dictated by the clinical team. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants With Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsPopulation: Only one participant developed changes in their allograft biopsies.
Calculations will be made from the start of abatacept through to 12 months post-transplant. A for-cause biopsy (i.e., graft dysfunction) may be performed in cases of increased serum creatinine, proteinuria, or other clinical symptoms at the discretion of the site Investigator.
Outcome measures
| Measure |
Abatacept
n=1 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Time to Changes in Allograft Biopsies for the 5 Categories of aTCMR Specified in the Banff Schema
|
28 days
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsNumber of participants who develop de-novo DSA
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Participants Who Develop De-novo Donor Specific Antibody (DSA)
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 months post-transplantationThe eGFR will be calculated at the time abatacept is started and 12 months post-transplant
Outcome measures
| Measure |
Abatacept
n=14 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Estimated Glomerular Filtration Rate (eGFR)
Baseline
|
67.5 mL/min/1.73 m^2
Standard Deviation 18.8
|
|
Estimated Glomerular Filtration Rate (eGFR)
12 months post-transplant
|
66.3 mL/min/1.73 m^2
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: Up to 12 months post-transplantation, an average of 8 monthsPopulation: Only one participant developed changes in their allograft biopsies.
All events will be documented, and calculations will be made from the start of abatacept through 12 months post-transplant.
Outcome measures
| Measure |
Abatacept
n=1 Participants
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Number of Days to Events [TCMR, ABMR, De-novo Specific Antibodies (DSA) Formation, Graft Loss].
|
28 days to acute rejection
|
Adverse Events
Abatacept
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abatacept
n=14 participants at risk
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Blood and lymphatic system disorders
Acute Rejection
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
Other adverse events
| Measure |
Abatacept
n=14 participants at risk
Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.
Abatacept 125Mg/Ml Syringe: Participants on qualifying belatacept regimen (with low dose tacrolimus, mmf and prednisone) will have their maintenance regimen changed from i.v. belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant:
Costimulation blockade:
\- Abatacept 125 mg subcutaneous weekly
|
|---|---|
|
Reproductive system and breast disorders
Hematospermia
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
Investigations
Increased creatinine
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
Immune system disorders
Possible Class II Donor-Specific Antibodies (DSA)
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
Infections and infestations
Viremia
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
Renal and urinary disorders
Acute kidney injury (AKI)
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
Investigations
Low white blood cell (WBC) count
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
|
General disorders
Irritability
|
7.1%
1/14 • Information on adverse events was collected from all participants throughout the study intervention and up to 12 months post-transplant, with an average of 8 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place