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Functional Genetic Variants Affecting Tacrolimus Trough Levels and Side Effects in Chinese Renal Transplantation.

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ClinicalTrials.gov Identifier: NCT03083769
Recruitment Status : Completed
First Posted : March 20, 2017
Results First Posted : November 20, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Third Affiliated Hospital, Sun Yat-Sen University
181 Central Hospital of the Chinese PLA
Information provided by (Responsible Party):
Liang Li, Southern Medical University, China

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Transplantation
Enrollment 1502
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 839 663
Completed 819 631
Not Completed 20 32
Arm/Group Title Cohort 1 Cohort 2 Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 839 663 1502
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 839 participants 663 participants 1502 participants
41.3  (11.6) 40.8  (10.6) 41.1  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 839 participants 663 participants 1502 participants
Female
263
  31.3%
189
  28.5%
452
  30.1%
Male
576
  68.7%
474
  71.5%
1050
  69.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 839 participants 663 participants 1502 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
839
 100.0%
663
 100.0%
1502
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 839 participants 663 participants 1502 participants
839 663 1502
1.Primary Outcome
Title Number of Participants With Acute Rejection
Hide Description 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.
Time Frame Day 1 to Day 61
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 819 631
Measure Type: Number
Unit of Measure: participants
256 37
2.Primary Outcome
Title Number of Participants With Tacrolimus-related Nephrotoxicities
Hide Description We 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.
Time Frame Day1 to Day 61
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 819 631
Measure Type: Number
Unit of Measure: participants
26 2
3.Primary Outcome
Title Number of Participants With Tacrolimus-related Neurotoxicities
Hide Description We 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.
Time Frame Day1 to Day 61
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 819 631
Measure Type: Number
Unit of Measure: participants
10 1
Time Frame Transplant recipients were followed for 61 days after transplantation to monitor side effects (acute rejection, nephrotoxicity and neurotoxicity).
Adverse Event Reporting Description All the participants are at risk for All-Cause Mortality.
 
Arm/Group Title Cohort 1 Cohort 2
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Cohort 1 Cohort 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/819 (0.00%)      0/631 (0.00%)    
Hide Serious Adverse Events
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   256/819 (31.26%)      37/631 (5.86%)    
Renal and urinary disorders     
Acute rejection  [1]  256/819 (31.26%)  256 37/631 (5.86%)  37
Indicates events were collected by systematic assessment
[1]
Acute rejection for kidney transplant recipients.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1 Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/819 (0.00%)      0/631 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Liang Li
Organization: Southern Medical University
Phone: 86 20 61648510
EMail: liliang@smu.edu.cn
Layout table for additonal information
Responsible Party: Liang Li, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT03083769    
Other Study ID Numbers: NFEC-2016-176
First Submitted: March 8, 2017
First Posted: March 20, 2017
Results First Submitted: October 12, 2019
Results First Posted: November 20, 2019
Last Update Posted: November 20, 2019