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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129961
Recruitment Status : Completed
First Posted : August 12, 2005
Results First Posted : March 23, 2012
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Skin Neoplasms Kidney Transplantation Drug: sirolimus Drug: cyclosporine or tacrolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : August 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: 1
Conversion to a sirolimus-based regimen
Drug: sirolimus
Active Comparator: 2
Continuation of a CNI-based regimen
Drug: cyclosporine or tacrolimus

Primary Outcome Measures :
  1. New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year [ Time Frame: up to 24 months ]
    The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.

Secondary Outcome Measures :
  1. Time to First Biopsy Confirmed New NMSC Lesion. [ Time Frame: up to 24 months ]
    The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.

  2. Number of Lesion Free Subjects [ Time Frame: up to 24 months ]
    The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.

  3. Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) [ Time Frame: up to 24 months ]
  4. Grade Distribution of NMSC Lesions [ Time Frame: up to 24 months ]
    Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).

  5. Number of Recurrent NMSC Lesions Per Subject-year [ Time Frame: up to 24 months ]
    Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.

  6. Subjects Reporting Incidence of Metastatic Disease Related to NMSC. [ Time Frame: up to 24 months ]
    The number of subjects with metastatic disease related to NMSC.

  7. Death Due to NMSC [ Time Frame: up to 24 months ]
  8. Number of Subjects Who Discontinue Assigned Therapy [ Time Frame: up to 24 months ]
  9. Nankivell-Calculated Glomerular Filtration Rate (GFR) [ Time Frame: At 24 months (week 104) ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.

  10. Serum Creatinine Level [ Time Frame: At 24 months (Week 104) ]
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.

  11. Number of Participants That Died [ Time Frame: up to 24 months ]
  12. Graft Survival Measured by Graft Loss [ Time Frame: up to 24 months ]
    Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.

  13. Number of Subjects With Biopsy-Confirmed Acute Rejection [ Time Frame: up to 24 months ]
  14. Spot Urine Protein:Creatinine Ratio [ Time Frame: At 24 months (Week 104) ]
    Subjects' urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129961

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United States, California
San Diego, California, United States, 92103
San Francisco, California, United States, 94143
United States, Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Atlanta, Georgia, United States, 30309
United States, Illinois
Chicago, Illinois, United States, 60612
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Wooloongabba, Queensland, Australia, 4102
Australia, South Australia
Woodville, South Australia, Australia, 5011
Adelaide, Australia, SA 5000
Clayton, Australia, VIC 3169
Herston, Australia, QLD 4029
Parkville, Australia, VIC 3050
Randwick, Australia, NSW 2031
Westmead, Australia, NSW 2145
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
New Zealand
Grafton, Auckland, New Zealand, 1031
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Canada,
Principal Investigator: Trial Manager For Australia,
Principal Investigator: Trial Manager For New Zealand,

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00129961    
Other Study ID Numbers: 0468H1-407
First Posted: August 12, 2005    Key Record Dates
Results First Posted: March 23, 2012
Last Update Posted: April 11, 2012
Last Verified: April 2012
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Skin Cancer
Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents