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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00037531
First received: May 17, 2002
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Graft vs Host Disease
Kidney Transplantation
Drug: Sirolimus (RAPAMUNE)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Official Title: An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 769
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037531

Locations
United States, California
Los Angeles, California, United States, 90057
Los Angeles, California, United States, 90095-1752
San Diego, California, United States, 92123
Stanford, California, United States, 94304
United States, Florida
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30322
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Indiana
Indianapolis, Indiana, United States, 46202-5250
United States, New York
New York, New York, United States, 10029
United States, North Carolina
Charlotte, North Carolina, United States, 28232
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19141
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Charleston, South Carolina, United States, 29425-0777
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal, Quebec, Canada, H2L 2W5
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00037531     History of Changes
Other Study ID Numbers: 0468E1-306
Study First Received: May 17, 2002
Last Updated: August 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Transplant
Kidney

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014