Study Evaluating Sirolimus in Kidney Transplant Recipients

NCT00195273

Last updated date
Study Location
Oslo, , N-0027, Norway
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

- Kidney transplantation

- Donor must be at least 60 years old.

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


- Current systemic infection


- Unstable angina or treatment for serious arrhythmia.


- Cancer within the previous 5 years.

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Graft vs Host Disease, Kidney TransplantationStudy Evaluating Sirolimus in Kidney Transplant Recipients
NCT00195273
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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+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Sirolimus in Kidney Transplant Recipients
Official Title  ICMJE A Randomized Open-Label Study Comparing the Efficacy and Safety of Sirolimus Combined With Daclizumab, Mycophenolate and Corticosteroids vs Cyclosporine, Mycophenolate and Corticosteroids in Renal Allograft Recipients Receiving Kidneys From Older Donors
Brief Summary The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Graft vs Host Disease
  • Kidney Transplantation
Intervention  ICMJE
  • Drug: sirolimus
    15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12
  • Drug: cyclosporine
    Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12
  • Drug: mycophenolate mofetil
    1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events
  • Drug: corticosteroids
    As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day
  • Drug: daclizumab
    IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
Study Arms  ICMJE
  • Experimental: 1
    Sirolimus + Daclizumab + Mycophenolate + Corticosteroids
    Interventions:
    • Drug: sirolimus
    • Drug: mycophenolate mofetil
    • Drug: corticosteroids
    • Drug: daclizumab
  • Active Comparator: 2
    Cyclosporine + Mycophenolate + Corticosteroids
    Interventions:
    • Drug: cyclosporine
    • Drug: mycophenolate mofetil
    • Drug: corticosteroids
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: July 31, 2009)
61
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
60
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Kidney transplantation
  • Donor must be at least 60 years old.

Exclusion Criteria:

  • Current systemic infection
  • Unstable angina or treatment for serious arrhythmia.
  • Cancer within the previous 5 years.
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 Norway,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00195273
Other Study ID Numbers  ICMJE 0468H-101466
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
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
Principal Investigator:Trial ManagerFor Norway, Sweden, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

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