Trial Information
Efficacy of Rapamycin in Secondary Prevention of Skin Cancers in Kidney Transplant Recipients - Multicentric Randomized, Open-label Study of Rapamycin vs Calcineurin Inhibitors
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the incidence of new squamous cell carcinoma in kidney transplant recipients
Outcome Time Frame:
during 5 years
Safety Issue:
No
Principal Investigator
Sylvie EUVRARD, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civils de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2003.333
NCT ID:
NCT00133887
Start Date:
April 2004
Completion Date:
March 2014
Related Keywords:
- Skin Cancer
- Kidney Transplantation
- Squamous cell carcinoma
- kidney transplant recipients
- rapamycin
- Skin cancers in kidney transplant recipients
- Skin Neoplasms