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 Details — Status: Completed

Administrative data

• NCT number: NCT00037531
• Other study ID #: 0468E1-306
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2002
• Last updated: August 17, 2009
• Est. completion date: August 2004

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 769
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Completion of sirolimus/blinded therapy in solid organ clinical trials (with or without CsA) with satisfactory compliance and an adequate safety profile.

• Women of childbearing potential who have a negative pregnancy test before enrollment into this study and who agree to practice either a hormonal or barrier method of birth control throughout the treatment period and for 3 months following discontinuation of sirolimus may be enrolled into the study.

• Signed and dated informed consent

Exclusion Criteria:

• Unstable disease states, which in the opinion of the investigator would present a risk to the patient.

• Known hypersensitivity to macrolide antibiotics

Study Design

Endpoint Classification: Safety Study

Related Conditions & MeSH terms

• Graft vs Host Disease
• Kidney Transplantation

Intervention

Drug:
• Sirolimus (RAPAMUNE)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Canada,