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OpenTrials
Completed

NCT Number: NCT00037531

Study Evaluating 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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Key information

Conditions

Graft vs Host Disease Immune System Diseases Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sirolimus (RAPAMUNE)

Drug

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune™) in Solid Organ Transplant Recipients

Important dates

Primary completion
2004
Study completion
2004
First posted
May 20, 2002
Registry last updated
Aug 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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