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

NCT00037531

Last updated date
Study Location
Los Angeles, California, 90057, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Graft vs Host Disease, Kidney Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Unstable disease states, which in the opinion of the investigator would present a risk
to the patient.


- Known hypersensitivity to macrolide antibiotics

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Graft vs Host Disease, Kidney TransplantationStudy Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
NCT00037531
  1. Los Angeles, California
  2. Los Angeles, California
  3. San Diego, California
  4. Stanford, California
  5. Tampa, Florida
  6. Atlanta, Georgia
  7. Augusta, Georgia
  8. Chicago, Illinois
  9. Indianapolis, Indiana
  10. New York, New York
  11. Charlotte, North Carolina
  12. Philadelphia, Pennsylvania
  13. Pittsburgh, Pennsylvania
  14. Charleston, South Carolina
  15. Edmonton, Alberta
  16. Vancouver, British Columbia
  17. Halifax, Nova Scotia
  18. Toronto, Ontario
  19. Toronto, Ontario
  20. Montreal, Quebec
ALL GENDERS
18 Years+
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Sirolimus (Rapamune?) in Solid Organ Transplant Recipients
Official Title  ICMJE An Open-label Extension Study of the Safety of Long-term Administration of Sirolimus (Rapamune?) in Solid Organ Transplant Recipients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Not Provided
Condition  ICMJE
  • Graft vs Host Disease
  • Kidney Transplantation
Intervention  ICMJE Drug: Sirolimus (RAPAMUNE)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 17, 2009)
769
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2004
Actual Primary Completion Date August 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037531
Other Study ID Numbers  ICMJE 0468E1-306
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

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