| 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
|
|
|
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
|
|
|
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. |