NCT00117689

Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection

A Randomized, Controlled, Multi-Center Study of Thymoglobulin Induction Therapy With a Calcineurin Inhibitor Sparing Regimen in Liver Transplant Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study involves the use of a drug called Thymoglobulin, which is approved in the US to treat kidney transplant rejection and in Canada to treat and prevent kidney transplant rejection. This study will evaluate the effect of Thymoglobulin induction therapy and reduced doses of calcineurin inhibitors on the incidence of liver rejection and will provide a basis for future evaluations of Thymoglobulin as an immunosuppressive agent to help decrease the incidence of liver transplant rejection. Subjects meeting all inclusion and exclusion criteria are eligible to participate in this study. Approximately 75 study subjects from up to 18 transplant centers in the United States and Canada will be enrolled in this 12-month study.

Conditions

• Liver Dysfunction
• Rejection, Transplant
• Transplantation, Liver

Interventions

Type	Name	Description
BIOLOGICAL	Thymoglobulin	Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy
DRUG	Corticosteroid	For a minimum of 3 months
DRUG	Tacrolimus	Between Day 3 the last dose of Thymoglobulin
DRUG	Mycophenolate Mofetil	for at least 1 month posttransplant

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-07-08
• Last updated: 2015-03-18

Locations

16 sites across 2 countries: United States, Canada