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Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:
An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Clinical Trial Summary

To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without cyclosporine (CsA). To evaluate the pharmacokinetics and safety of long-term administration of sirolimus tablets administered for up to 5 years, or until the tablet formulation is commercially available in solid organ transplant recipients who are currently receiving sirolimus and who have completed clinical trials with sirolimus (with or without CsA) or who are currently enrolled in protocol 0468E1-306-US.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety Study

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00037531
Study type Interventional
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status Completed
Phase Phase 3
Completion date August 2004
View Details
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