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

Wyeth

Status and phase: Completed; Phase 3

Conditions: Graft vs Host Disease; Kidney Transplantation

Treatments: Drug: Sirolimus (RAPAMUNE)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00037531

0468E1-306

Details and patient eligibility

About

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.

Enrollment: 769 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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