Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation; Skin Neoplasms

Treatments: Drug: sirolimus; Drug: cyclosporine or tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129961

0468H1-407

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

1

Experimental group

Description:

Conversion to a sirolimus-based regimen

Treatment:

Drug: sirolimus

2

Active Comparator group

Description:

Continuation of a CNI-based regimen

Treatment:

Drug: cyclosporine or tacrolimus