NCT00037531

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 769 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft vs Host Disease
• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Sirolimus (RAPAMUNE)

Timeline

• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2002-05-20
• Last updated: 2009-08-18

Locations

20 sites across 2 countries: United States, Canada