Research

Use of Sirolimus in Liver Transplant Patients

Pharmacokinetics of Sirolimus Conversion in Liver Transplant Recipients with Early Nephrotoxicity Due to Tacrolimus

Protocol Description

This research study will measure the effectiveness of the anti-rejection drugs tacrolimus and sirolimus used in transplantation on graft rejection, kidney function and on blood pressure. Preliminary studies suggest sirolimus may prove to be a suitable alternative to tacrolimus because it may improve kidney function and reduce high blood pressure. Indications show that sirolimus may also reduce the chances of seizures in children who have received liver, intestine, or thoracic transplants.

Eligibility Criteria

Eligible candidates for this study include both male and female liver transplant recipients between the ages of 5 and 30 years, who are currently receiving tacrolimus as an anti-rejection drug, but are showing signs that kidney function is less than would be expected and/or needs medications to treat high blood pressure.
Males: Ages 5 to 30 years
Females: Ages 5 to 30 years

Requirements
Participants will be admitted to the Pediatric Clinical and Translational Research Center (PCTRC) for a day of kidney function tests, blood tests and the initial dose of sirolimus. Follow-up visits to the PCTRC will be required over the duration of the study. After a combined treatment involving both drugs, tacrolimus will be phased out and sirolimus will become the anti-rejection drug.
Visits: 3
Duration: 1 year

Status: Open for Enrollment

Sources of Support
Pediatric Transplantation Department, Children’s Hospital of Pittsburgh of UPMC
Pediatric Clinical and Translational Research Center