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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Page 1 of 6 (23 locations)

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