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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
San Diego, California, 92103 United States
Contact
1-800-718-1021
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

NCT00129961
Pfizer
Completed
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

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Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Skin Neoplasms
  • Kidney Transplantation
  • Drug: sirolimus
  • Drug: cyclosporine or tacrolimus
  • 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
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.
 
Completed
86
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   New Zealand,   United States
 
 
NCT00129961
0468H1-407
No
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Canada, [email protected]
Principal Investigator: Trial Manager For Australia, [email protected]
Principal Investigator: Trial Manager For New Zealand, [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
April 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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