drugset / Trial / NCT00369382

Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

NCT00369382

Phase 4 Completed 121 enrolled Wyeth is now a wholly owned subsidiary of Pfizer
RandomizedParallel-groupOpen-labelPrevention

Summary

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Timeline

Start
2006-09
Primary completion
2010-04
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide
Subject Sirolimus Small molecule 1 mg Oral
Subject Sirolimus Small molecule 2 mg Oral
Comparator Tacrolimus Small molecule