Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

NCT00129961

Last updated date
Study Location
San Diego, California, 92103, 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.
Skin Neoplasms, 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 transplant at least 1 year prior

- Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.

- Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen

- History of NMSC within last 3 years

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


- History of other cancer within last 3 years


- NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months


- Multiple organ transplant

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Skin Neoplasms, Kidney TransplantationStudy Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
NCT00129961
  1. San Diego, California
  2. San Francisco, California
  3. Gainesville, Florida
  4. Atlanta, Georgia
  5. Chicago, Illinois
  6. Durham, North Carolina
  7. Cincinnati, Ohio
  8. Portland, Oregon
  9. Philadelphia, Pennsylvania
  10. Charleston, South Carolina
  11. Nashville, Tennessee
  12. Madison, Wisconsin
  13. Camperdown, New South Wales
  14. Wooloongabba, Queensland
  15. Woodville, South Australia
  16. Adelaide,
  17. Clayton,
  18. Herston,
  19. Parkville,
  20. Randwick,
  21. Westmead,
  22. Vancouver, British Columbia
  23. Grafton, Auckland
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
Official Title  ICMJE A Randomized, Open-Label Study to Compare the Rate of New Non-Melanoma Skin Cancer in Maintenance Renal Allograft Recipients Converted to a Sirolimus-based Regimen Versus Continuation of a Calcineurin Inhibitor-based Regimen
Brief Summary The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Skin Neoplasms
  • Kidney Transplantation
Intervention  ICMJE
  • Drug: sirolimus
  • Drug: cyclosporine or tacrolimus
Study Arms  ICMJE
  • Experimental: 1
    Conversion to a sirolimus-based regimen
    Intervention: Drug: sirolimus
  • Active Comparator: 2
    Continuation of a CNI-based regimen
    Intervention: Drug: cyclosporine or tacrolimus
Publications * Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15.

*   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: February 17, 2012)
86
Original Enrollment  ICMJE
 (submitted: August 11, 2005)
200
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Kidney transplant at least 1 year prior
  • Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ?40mL/min (Nankivell method) and proteinuria ?500mg/day.
  • Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
  • History of NMSC within last 3 years

Exclusion Criteria:

  • History of other cancer within last 3 years
  • NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months
  • Multiple organ transplant
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 Australia,   Canada,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129961
Other Study ID Numbers  ICMJE 0468H1-407
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Canada, [email protected]
Principal Investigator:Trial ManagerFor Australia, [email protected]
Principal Investigator:Trial ManagerFor New Zealand, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2012

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