Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00037531

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 III

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Sirolimus

U.S. FDA Resources

Further study details as provided by Wyeth:

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

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

Locations

United States, California

Los Angeles, California, United States, 90057

San Diego, California, United States, 92123

Stanford, California, United States, 94304

Los Angeles, California, United States, 90095-1752
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

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

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

Keywords provided by Wyeth:

Transplant
Kidney

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Graft vs Host Disease

ClinicalTrials.gov processed this record on November 27, 2009