drugset / Trial / NCT00248313

Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus

NCT00248313

Phase 3 Completed 470 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelPrevention

Summary

To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA dose reduction and concentration-controlled Rapamune® versus induction with CsA and Rapamune® followed by discontinuation of CsA and concentration-controlled Rapamune®.

Timeline

Start
2000-07
Primary completion
Completion
2007-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule

Indications