TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients

Hospices Civils de Lyon77 enrolled

Overview

In a population of kidney transplant recipients having developed a first squamous cell carcinoma, the aim of the study is to assess the incidence of subsequent skin cancers over 2 years in patients who are switched to rapamycin as compared to patients who are maintained under calcineurin inhibitors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin Cancer Kidney Transplantation

Interventions

rapamycinDRUG

3 to 5 mg/day

ciclosporineDRUG

Blood residual level \< or = to 125 ng/ml

tacrolimusDRUG

Blood residual level \< or = to 8 ng/ml

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors Exclusion Criteria: * Other squamous cell carcinomas in the past history * More than 2 transplantations * Patients not under calcineurin inhibitors * Unstable graft function * Non controlled hyperlipidemia (cholesterol \> 7.8 mmol/l or triglycerides \> 3.95 mmol/l) * Leucopenia \< 3000/mm3 * Thrombocytopenia \< 100,000/mm3 * Liver dysfunction * Pregnancy * Allergy to macrolides

Locations (1)

Hôpital Edouard Herriot - Service de Dermatologie

Lyon, France

Outcomes

Primary Outcomes

To assess the incidence of new squamous cell carcinoma in kidney transplant recipients

Time frame: during 5 years

Secondary Outcomes

To assess the incidence of other non skin cancer in kidney transplant recipients

Time frame: during 5 years

To assess the graft survival

Time frame: during 5 years

To assess the tolerance of rapamycin

Time frame: during 5 years

Data from ClinicalTrials.gov

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