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
Conditions
Interventions
Trade Name: GLOBULINES ANTILYMPHOCYTAIRES FRESENIUS
Pharmaceutical Form: Solution for infusion
Trade Name: SIMULECT
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
CHU Saint-Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient aged = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Panel Reactive Antibody (PRA PRA global or class I or class II PRA) over 50% on a serum before transplantation -Multi-organ graft -Transplants using donor limits or sub-optimal: donor age = 70 years, donors in the study BIGRAS or taken heart beating donors (tested on computer infusion) or other restriction factors - IgA glomerulonephritis secondary to HSP (Henoch-Schonlein purpura) or Systemic Lupus Erythematosus (SLE) or alcoholic cirrhosis - History of cancer older than 5 years or with advanced cancer, but except for non-recurrent skin cancers - Infectious diseases scalable: tuberculosis, HIV, HBV or HCV infection with viral replication and / or chronic hepatitis - Allergy to rabbit proteins - Severe thrombocytopenia (<50,000 platelets / ul) - Bacterial infection, viral and fungal uncontrolled therapeutically - Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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. ;Primary end point(s): Clinico-histological recurrence of IgA in monitoring a first transplant | — |
Countries
France, Spain
Outcome results
None listed