Eficacia de rapamicina en prevención secundaria de tumores cutáneos en trasplantados renales. Estudio abierto, aleatorizado, comparando rapamicina con inhibidores de calcineurina. - Tumorapa-1
- Conditions
- Comparar el efecto de dos estrategias inmunosupresoras sobre la incidencia de nuevos carcinomas espinocelulares en pacientes con trasplante renal que hayan desarrollado un primer carcinoma espinocelular.To evaluate the impact of two imnosupressive regimens on the incidence of skin cancers among patients who has a first spinocellular skin cancer after renal transplantationMedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant
- Registration Number
- EUCTR2004-004947-23-ES
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
patient aged 18 year old or more with kidney transplant with immunosuppressive treatment with calcineurines inhibitor recurrence of spinocellular carcinoma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
patient aged les tha 18 year old
metastatic carcinoma
previous treatment with rapamycine
pregnant woman
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Rapapmycine replacement of calcineurines inhibitor could reduce the risk of a new kin cancer by 40% or more while preserving graft function;Secondary Objective: ;Primary end point(s): to analyse the annual incidence of spinocellular carcinoma
- Secondary Outcome Measures
Name Time Method