TerminatedPhase 4

Trial of Calcineurin Inhibitor-Sparing Immunosuppression Regimen in Pediatric Liver Transplantation

Stopped: insufficient funding

United States13 participantsStarted 2004-11

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * End-stage liver disease or acute fulminant hepatic failure recalcitrant to conventional medical or surgical therapy. * Listed as candidate for pediatric liver transplantation listed with United Network for Organ Sharing (UNOS). * Patients must be 18 years of age or younger. Exclusion Criteria: * History of autoimmune disease or primary sclerosing cholangitis. * History of end-stage renal disease, dialysis treatment or acute renal failure (not including hepatorenal syndrome). * Patients with pretransplant renal insufficiency as determined by a glomerular filtration rate (GFR) of \<80 mL/min/1.73m2 (see below). * Patients with renal agenesis or hypoplasia, polycystic kidney disease, or hydroureter seen on pretransplant renal ultrasound. * Patients with malignancy or previous malignancy. * Patients with active bacterial, viral, or fungal infections. * Patients with a pretransplant diagnosis of diabetes mellitus. * Patients with history of previous transplant or multi-organ recipients. * Patients with serological evidence of HIV, HBSAg or HCV. * Patients with hereditary syndrome that causes genetic deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan or Kelley-Seegmiller syndrome. * Patients with history of phenylketonuria. * Females that are pregnant or breastfeeding. * Sexually active females who are not: a) post-menopausal, or b) surgically sterile, and c) using an acceptable method of contraception (oral contracept…

What they're measuring

change in glomerular filtration rate (GFR) two years after liver transplantation as calculated by the Schwartz formula

Timeframe: two years

Trial details

NCT IDNCT00656266

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-11