Status:
COMPLETED
Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Skin Neoplasms
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00129961
Start Date
August 1 2005
End Date
January 1 2009
Last Update
April 11 2012
Active Locations (23)
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1
San Diego, California, United States, 92103
2
San Francisco, California, United States, 94143
3
Gainesville, Florida, United States, 32610
4
Atlanta, Georgia, United States, 30309