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
18 Years
N/A
Both
Skin Neoplasms, Kidney Transplantation
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year
Outcome Description:
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.
Outcome Time Frame:
up to 24 months
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
0468H1-407
NCT ID:
NCT00129961
Start Date:
August 2005
Completion Date:
January 2009
Related Keywords:
- Skin Neoplasms
- Kidney Transplantation
- Kidney
- Transplant
- Skin Cancer
- Neoplasms
- Skin Neoplasms
- Carcinoma, Basal Cell
- Carcinoma, Basosquamous
- Carcinoma, Squamous Cell
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Albany, Georgia 31701 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Charleston, South Carolina |
