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CTRI Number  CTRI/2024/12/078003 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 06/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   To study the effects of a gene variation on the blood of the drug tacrolimus and its effect on transplant kidney function in kidney transplant patients. 
Scientific Title of Study   A prospective observational study on the difference in blood AUC (Area under concentration–time curve) levels of tacrolimus between non-expressers and expressers of CYP3A5 gene polymorphism and its effect on graft outcomes in renal allograft recipients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemalatha S 
Designation  Senior resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Nephrology Christian Medical College Ranipet Campus Kilminnal village Vellore

Vellore
TAMIL NADU
632517
India 
Phone  9095088348  
Fax    
Email  hemalatha.s@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Santosh Varughese 
Designation  Professor 
Affiliation  Christian Medical College Vellore 
Address  Head of Unit 2, Department of Nephrology, Christian Medical College, Ranipet Campus, Kilminnal village, Vellore.

Vellore
TAMIL NADU
632517
India 
Phone  9442380267  
Fax    
Email  santosh.vellore@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemalatha S 
Designation  Senior resident 
Affiliation  Christian Medical College Vellore 
Address  Department of Nephrology Christian Medical College Ranipet Campus Kilminnal village Vellore


TAMIL NADU
632517
India 
Phone  9095088348  
Fax    
Email  hemalatha.s@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Christian Medical College, Fluid research grant, Department of Nephrology, Kilminnal village, Ranipet campus, Tamilnadu, India. PIN 632517 
 
Primary Sponsor  
Name  Christian Medical College 
Address  Fluid research grant Department of Nephrology Christian Medical College Ranipet Campus, Kilminnal village, Tamilnadu, India. PIN 632517 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hemalatha S  Christian Medical College  Dept of Nephrology, Christian Medical College, Ranipet Campus, Kilminnal village, India.
Vellore
TAMIL NADU 
9095088348

hemalatha.s@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Research, Institutional Review Board, Christian Medical College, Vellore, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Expressors of CYP3A5 gene polymorphism  Blood AUC (Area under concentration–time curve) levels of tacrolimus in expressers of CYP3A5 gene polymorphism 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All consecutive prospective low immunological risk renal allograft recipients planned for triple immunosuppression prednisolone, mycophenolate mofetil, and tacrolimus. 
 
ExclusionCriteria 
Details  Patients who
1)required a switch from tacrolimus regimen to cyclosporine or everolimus, undergoing deceased donor transplant, in high immunological risk categories like ABO incompatible, requiring HLA desensitization, re-transplant, on current therapy with bile acid sequestrants – cholestyramine, hypoalbuminemia, Poor drug compliance, Graft dysfunction due to surgical complications.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean difference tacrolimus AUC levels in Expressers Vs Non-Expressers among renal allograft recipients at Day 5 post Renal transplant
 
5th day, 1,3,6,12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Tacrolimus Trough levels in Expressers Vs Non-expressers at 1,3,6,12-month post-transplant
2. Dose normalized trough concentrations of Tacrolimus at 1month post-transplant between the 2 groups
3. Dose adjusted Tacrolimus AUC levels in Expressers Vs Non-expressers at 1,3,6,10-12 months post-transplant.
4. Cumulative dosage required to maintain adequate therapeutic levels in both groups
5. Prevalence of various CYP3A5 polymorphisms among the renal allograft recipient population at our institute
6. Correlation of Tacrolimus AUC levels with graft function. Slow/delayed Graft function (At 1-week post-transplant) and biopsy-proven acute rejection among both groups.
7. Correlation of Tacrolimus AUC levels with drug toxicity among both groups
 
1,3,6,10,12 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

To study the effects of genetic variation and blood levels of the drug tacrolimus and transplant kidney function in kidney transplant recipient patients in tertiary care hospital. Tacrolimus is an important drug used for suppressing immunity and preventing kidney graft loss. But Tacrolimus drug level in blood should be maintained within a narrow range from 4-11 ng/ml post renal transplant. Tacrolimus is eliminated from the body by the effect of the CYP3A5 gene. Patients in general can have varied gene pattern. If the patient has no genetic variation (non-Expressers), the tacrolimus level will be higher than the recommended range and will lead to toxicity. If the patient has genetic variation (Expressers), tacrolimus level is low than this range it will lead to graft rejection. Thus, it is important to find out the variation in genetics and to study the effects of genetic variation and how it affects tacrolimus blood levels which are necessary for the maintenance of the graft to function properly. This could potentially save graft function and survival.

 

 This study basically aims to determine if by finding out the genetic variation which affects tacrolimus blood levels, we can give tacrolimus dosage accordingly so that it will be beneficial to avoid either graft loss on one hand if levels are low and tacrolimus toxicity if blood level and exposure is high on another hand. All patients enrolled in the study will be given tacrolimus 0.13mg/kg to look at therapeutic blood levels and to assess for kidney graft function in the form of rejection and drug toxicity. Also, we will find out how frequent is genetic variation among our population in CMC and its effect on graft survival.

 

 

 
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