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 transplantation MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant
Conditions
Interventions
Trade Name: Neoral
Product Name: Cyclosporine
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: cyclosporine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: patient aged les tha 18 year old metastatic carcinoma previous treatment with rapamycine pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Outcome results
None listed