drugset / Trial / NCT00195468

Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

NCT00195468

Phase 4 Completed 280 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).

Timeline

Start
2004-03
Primary completion
2006-11
Completion
2006-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide
Subject Sirolimus Small molecule