Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation
Status:
Terminated
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to compare the effects of two liver transplant
immunosuppression regimens on renal function. Patients receiving the standard combination of
prednisone and high-dose tacrolimus, a drug with known nephrotoxicity (Arm A) will be
compared to patients receiving prednisone, low-dose tacrolimus and mycophenolate mofetil
(MMF) (Arm B). MMF is an immunosuppression agent that has no associated nephrotoxicity. The
primary end point of the study will be renal function as measured by glomerular filtration
rate (GFR). Thirty pediatric liver transplant recipients will be randomized to these two arms
in a 1:1 ratio (i.e. 15 patients in each group). Secondary end points will measure patient
and graft outcome and incidence of immunosuppression-related complications, including:
neurotoxicity, diabetes mellitus, growth retardation, vomiting, diarrhea, gastrointestinal
hemorrhage, thrombocytopenia, anemia, leukopenia, acute or chronic liver graft rejection,
posttransplant lymphoproliferative disease (PTLD), viral infections, fungal infections and
bacterial infections.