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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.

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 - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078003
Enrollment
50
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N186- End stage renal disease

Interventions

Intervention1: Expressors of CYP3A5 gene polymorphism: Blood AUC (Area under concentration–time curve) levels of tacrolimus in expressers of CYP3A5 gene polymorphism Control Intervention1: Non-express

Sponsors

Christian Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive prospective low immunological risk renal allograft recipients planned for triple immunosuppression prednisolone, mycophenolate mofetil, and tacrolimus.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Mean difference tacrolimus AUC levels in Expressers Vs Non-Expressers among renal allograft recipients at Day 5 post Renal transplant Timepoint: 5th day, 1,3,6,12 months—

Secondary

MeasureTime frame
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 Timepoint: 1,3,6,10,12 months—

Countries

India

Contacts

Public ContactDr Hemalatha S

Christian Medical College Vellore

santosh.vellore@gmail.com9442380267

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026