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
1 other identifier
interventional
769
2 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2002
CompletedFirst Posted
Study publicly available on registry
May 20, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedAugust 18, 2009
August 1, 2009
May 17, 2002
August 17, 2009
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Los Angeles, California, 90095-1752, United States
Unknown Facility
San Diego, California, 92123, United States
Unknown Facility
Stanford, California, 94304, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Augusta, Georgia, 30912, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Indianapolis, Indiana, 46202-5250, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Charlotte, North Carolina, 28232, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Charleston, South Carolina, 29425-0777, United States
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 2Y9, Canada
Unknown Facility
Toronto, Ontario, M5B 1W8, Canada
Unknown Facility
Toronto, Ontario, M5G 2C4, Canada
Unknown Facility
Montreal, Quebec, H2L 2W5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer