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
1 other identifier
interventional
86
4 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2005
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedFirst Posted
Study publicly available on registry
August 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
March 23, 2012
CompletedApril 11, 2012
April 1, 2012
3.4 years
August 1, 2005
January 29, 2010
April 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
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.
up to 24 months
Secondary Outcomes (14)
Time to First Biopsy Confirmed New NMSC Lesion.
up to 24 months
Number of Lesion Free Subjects
up to 24 months
Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)
up to 24 months
Grade Distribution of NMSC Lesions
up to 24 months
Number of Recurrent NMSC Lesions Per Subject-year
up to 24 months
- +9 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALConversion to a sirolimus-based regimen
2
ACTIVE COMPARATORContinuation of a CNI-based regimen
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Gainesville, Florida, 32610, United States
Unknown Facility
Atlanta, Georgia, 30309, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Philadelphia, Pennsylvania, 19102, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Camperdown, New South Wales, 2050, Australia
Unknown Facility
Wooloongabba, Queensland, 4102, Australia
Unknown Facility
Woodville, South Australia, 5011, Australia
Unknown Facility
Adelaide, SA 5000, Australia
Unknown Facility
Clayton, VIC 3169, Australia
Unknown Facility
Herston, QLD 4029, Australia
Unknown Facility
Parkville, VIC 3050, Australia
Unknown Facility
Randwick, NSW 2031, Australia
Unknown Facility
Westmead, NSW 2145, Australia
Unknown Facility
Vancouver, British Columbia, V5Z 1M9, Canada
Unknown Facility
Grafton, Auckland, 1031, New Zealand
Related Publications (1)
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.
PMID: 22420843DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
A blinded review of data in May 2007 determined there was minimal added power in follow-up through 2 years vs. 1 year. The study was then amended to require at least 1 year of follow-up instead of 2 years.
Results Point of Contact
- Title
- U. S. Contact Center
- Organization
- Wyeth
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Canada, clintrialparticipation@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Australia, medinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For New Zealand, medinfo@wyeth.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2005
First Posted
August 12, 2005
Study Start
August 1, 2005
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
April 11, 2012
Results First Posted
March 23, 2012
Record last verified: 2012-04