Interest of rapamicin (Rapamune(R)) for the secondary prevention of skin cancers in kidney transplant recipients with more than one Spinocellar Carcinoma

Machine translation Machine translation
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Neoral 50 mg Product Name: Neoral Pharmaceutical Form: Capsule* INN or Proposed INN: cyclosporine Concentration unit: mg milligram(s) Concentration number: 50‐ Trade Name: rapamune 1mg Product Name: Rapamune Pharmaceutical Form: Capsule* INN or Proposed INN: rapamycine Concentration unit: mg milligram(s) Concentration number: 1‐ Trade Name: Neoral 100 mg Product Name: neoral Pharmaceutical Form: Capsule* INN or Proposed INN: cyclosporine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: rapamune 2 mg Product Name: Rapamune Pharmaceutical Form: Capsule* INN or Proposed INN: rapamycine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2‐ CONDITION: 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 PRIMARY OUTCOME: Main Objective: Rapamycine replacement of calcineurines inhibitor could reduce the risk of a new skin cancer by 40% or more while preserving graft function Primary end point(s): to analyse the annual incidence of spinocellular carcinoma Secondary Objective: 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.
Epistemonikos ID: a46de1028b4bae11b9330ec3457fb86e34fbf8da
First added on: Aug 21, 2024
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