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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Skin Neoplasms, Kidney Transplantation

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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