Prévention chez le receveur avec néphropathie à IgA primaire (NIGA) de la Récidive Après Transplantation rénale: ATG-F versus Basiliximab, comme traitements immunosuppresseurs d’induction. Etude PIRAT: a vs B - PIRAT

INTERVENTION:

Trade Name: GLOBULINES ANTILYMPHOCYTAIRES FRESENIUS Pharmaceutical Form: Solution for infusion Trade Name: SIMULECT Pharmaceutical Form: Powder and solvent for solution for injection

CONDITION:

IgA glomerulonephritis and first transplant ; MedDRA version: 12.1 Level: LLT Classification code 10018367 Term: Glomerulonephritis chronic ; MedDRA version: 12.1 Level: LLT Classification code 10023438 Term: Kidney transplant

PRIMARY OUTCOME:

Main Objective: Demonstration of a protective effect of ATG‐Fresenius against the clinical and histological recurrence of IgA nephropathy after primary first kidney transplant and compared to simulect Primary end point(s): Clinico‐histological recurrence of IgA in monitoring a first transplant Secondary Objective: For the efficacy, Comparison in the 2 groups :; ‐ histological recurrence confirmed by renal biopsy at 5 years ; ‐ graft loss ; ‐ quality of graft function at 5 years ; ‐ cumulative incidence of acute rejection and / or chronic rejection proved by renal biopsy to 5 years ; ‐ onset of hypertension; ‐ survival of grafts and patients up to 5 years ; For the safety, comparison in the 2 goups :; ‐ infection and CMV disease at 1 year ; ‐ other microbial infections at 1 year post‐transplant. ; ‐ incidence of cancers up to 5 years with 3 topics: skin cancer, cancers of organs (solid) and lymphomas. ;

INCLUSION CRITERIA:

‐ Patient aged = 18 and <75 years ‐ Free, informed, express and written. ‐ Diagnosis of native kidney primary IgA glomerulonephritis biopsy‐proven ‐ First kidney transplantation (one kidney) 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