drugset / Trial / NCT00261820

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

NCT00261820

Phase 4 Completed 160 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.

Timeline

Start
Primary completion
Completion
2005-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule
Subject Tacrolimus Small molecule
Background Methylprednisolone Other / unclassified
Background Mycophenolate Mofetil Small molecule
Background Prednisolone Other / unclassified