drugset / Trial / NCT00195273

Study Evaluating Sirolimus in Kidney Transplant Recipients

NCT00195273

Phase 3 Completed 61 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.

Timeline

Start
2004-11
Primary completion
2008-07
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide 10 mg/kg
Subject Daclizumab Monoclonal antibody 1 mg/kg Intravenous
Subject Sirolimus Small molecule 5 mg
Background Mycophenolate Mofetil Small molecule 1 g
Background Prednisolone Other / unclassified 5 mg
Background Prednisolone Other / unclassified 7.5 mg