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

May 17, 2002
August 17, 2009
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August 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00037531 on ClinicalTrials.gov Archive Site
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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

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.

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Interventional
Phase 3
Endpoint Classification: Safety Study
  • Graft vs Host Disease
  • Kidney Transplantation
Drug: Sirolimus (RAPAMUNE)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
769
August 2004
August 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00037531
0468E1-306
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Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP