El objetivo principal consiste en comparar el efecto de dos estrategias inmunosupresoras, sobre la incidencia de carcinomas espinocelulares nuevos en pacientes receptores de trasplante renal que hayan desarrollado más de un carcinoma espinocelular. To evaluate the impact of two immunosuppressive regimens on the incidence of skin cancers among patients who have had previously a first spinocellulaire skin cancer after transplantation
Conditions
Interventions
Trade Name: Rapamune
Product Name: Rapamune
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
INN
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patient aged 18 year old or more with kidney transplant with immunusuppressive 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 less than 18year old metastatic carcinoma previous treatment with rapamycine pregnant woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Rapamycine replacement of calcineurines inhibitor could reduce the risk of a new skin 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