Trial Outcomes & Findings for Functional Genetic Variants Affecting Tacrolimus Trough Levels and Side Effects in Chinese Renal Transplantation. (NCT NCT03083769)
NCT ID: NCT03083769
Last Updated: 2019-11-20
Results Overview
We will measure the number of participants with acute rejection during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for acute rejection in participants with different genotypes.
Recruitment status
COMPLETED
Target enrollment
1502 participants
Primary outcome timeframe
Day 1 to Day 61
Results posted on
2019-11-20
Participant Flow
Participant milestones
| Measure |
Cohort 1
The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Cohort 2
The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
|---|---|---|
|
Overall Study
STARTED
|
839
|
663
|
|
Overall Study
COMPLETED
|
819
|
631
|
|
Overall Study
NOT COMPLETED
|
20
|
32
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Genetic Variants Affecting Tacrolimus Trough Levels and Side Effects in Chinese Renal Transplantation.
Baseline characteristics by cohort
| Measure |
Cohort 1
n=839 Participants
The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Cohort 2
n=663 Participants
The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Total
n=1502 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
576 Participants
n=5 Participants
|
474 Participants
n=7 Participants
|
1050 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
839 Participants
n=5 Participants
|
663 Participants
n=7 Participants
|
1502 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
839 participants
n=5 Participants
|
663 participants
n=7 Participants
|
1502 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 61We will measure the number of participants with acute rejection during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for acute rejection in participants with different genotypes.
Outcome measures
| Measure |
Cohort 1
n=819 Participants
The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Cohort 2
n=631 Participants
The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
|---|---|---|
|
Number of Participants With Acute Rejection
|
256 participants
|
37 participants
|
PRIMARY outcome
Timeframe: Day1 to Day 61We will measure the number of participants with tacrolimus-related nephrotoxicities during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for tacrolimus-related nephrotoxicities in participants with different genotypes.
Outcome measures
| Measure |
Cohort 1
n=819 Participants
The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Cohort 2
n=631 Participants
The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
|---|---|---|
|
Number of Participants With Tacrolimus-related Nephrotoxicities
|
26 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Day1 to Day 61We will measure the number of participants with tacrolimus-related neurotoxicities during the day 1 to day 61 after transplantation. Kaplan-Meier analyses were performed for tacrolimus-related neurotoxicities in participants with different genotypes.
Outcome measures
| Measure |
Cohort 1
n=819 Participants
The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Cohort 2
n=631 Participants
The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
|---|---|---|
|
Number of Participants With Tacrolimus-related Neurotoxicities
|
10 participants
|
1 participants
|
Adverse Events
Cohort 1
Serious events: 256 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 37 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=819 participants at risk
The retrospective cohort consists of about 839 kidney transplant recipients from Nanfang Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
Cohort 2
n=631 participants at risk
The retrospective cohort consists of about 663 kidney transplant recipients from Guilin No. 924 Hospital. These patients used tacrolimus as immunosuppressive drug for preventing the rejection.The side effects (acute rejection, nephrotoxicity and neurotoxicity) will be recorded.
|
|---|---|---|
|
Renal and urinary disorders
Acute rejection
|
31.3%
256/819 • Number of events 256 • Transplant recipients were followed for 61 days after transplantation to monitor side effects (acute rejection, nephrotoxicity and neurotoxicity).
All the participants are at risk for All-Cause Mortality.
|
5.9%
37/631 • Number of events 37 • Transplant recipients were followed for 61 days after transplantation to monitor side effects (acute rejection, nephrotoxicity and neurotoxicity).
All the participants are at risk for All-Cause Mortality.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place