Examining genetic factors affecting tacrolimus levels in pediatric liver transplant recipients
Prevalence of CYP3A5 Polymorphisms in the Donors and ABCB1 Polymorphisms in the Recipients Undergoing Pediatric Liver Transplant and Their Influence on Tacrolimus Levels and Graft Function.
This study is testing how certain genetic differences in liver transplant donors and recipients affect the medication levels of tacrolimus and the health of the liver in children who have had a transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi) |
| Trial ID | NCT06361732 on ClinicalTrials.gov |
What this trial studies
This study investigates the prevalence of genetic polymorphisms in CYP3A5 among liver transplant donors and ABCB1 among recipients, focusing on their impact on tacrolimus levels and graft function in pediatric patients. It aims to compare the time taken to achieve stable liver enzyme levels in recipients receiving grafts from slow versus fast metabolizer donors. The study will involve both retrospective and prospective data collection from pediatric liver transplant cases over a 12-year period. Blood samples will be analyzed for genetic variations, and tacrolimus levels and graft function will be monitored according to standard protocols.
Who should consider this trial
Good fit: Ideal candidates include pediatric liver transplant recipients aged 0-18 years who have undergone transplantation from September 2011 to October 2023.
Not a fit: Patients who may not benefit include those with incomplete medical records, deceased donor transplants, or specific complications such as hepatic artery thrombosis or biliary complications.
Why it matters
Potential benefit: If successful, this study could lead to personalized immunosuppressive therapy, improving graft survival and reducing toxicities in pediatric liver transplant recipients.
How similar studies have performed: While this approach is based on established pharmacogenomic principles, the specific investigation of CYP3A5 and ABCB1 polymorphisms in pediatric liver transplant settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - All Pediatric Living donor liver Transpalnt Liver transplant recipients (0-18 years of age) from September 2011 till October 2023 with follow-up at least for 1 year. Exclusion Criteria: 1. Incomplete medical records 2. Non-availability of Donor to check CYP3A5 polymorphism Deceased donor liver transplantation 3. Primary non-function 4. Mortality within 2 weeks of liver transplantation Re-transplantation 5. Children with Hepatitis C infection 6. Multi-visceral or Combined liver-kidney transplantation 7. Hepatic artery thrombosis within 6 months of liver transplantation 8. Biliary complications within 6 months of liver transplantation requiring intervention
Where this trial is running
New Delhi
- Institute of Liver and Biliary Sciences — New Delhi, India (Recruiting)
Study contacts
- Study coordinator: Dr Snigdha Verma, MD
- Email: dr.snigdha1@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.