TUMORAPA 1: Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients
Phase 3
Completed
- Conditions
- Kidney TransplantationSkin Cancer
- Interventions
- Registration Number
- NCT00133887
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
Inclusion Criteria
- First post-transplant squamous cell carcinoma in a kidney transplant recipient under calcineurin inhibitors
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 rapamycin patients receiving Rapamycin 2 ciclosporine patients receiving anticalcineurin treatment 2 tacrolimus patients receiving anticalcineurin treatment
- Primary Outcome Measures
Name Time Method To assess the incidence of new squamous cell carcinoma in kidney transplant recipients during 5 years
- Secondary Outcome Measures
Name Time Method To assess the incidence of other non skin cancer in kidney transplant recipients during 5 years To assess the graft survival during 5 years To assess the tolerance of rapamycin during 5 years
Trial Locations
- Locations (1)
Hôpital Edouard Herriot - Service de Dermatologie
🇫🇷Lyon, France