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

Completed · Phase 3

Conditions studied: Graft vs Host Disease, Kidney Transplantation

In brief

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.

Key facts

Study ID

NCT00037531

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

769

Expected to finish

2004-08-01

Last updated by the study team

2009-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.