Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy ; a Pilot Phase II Study.

RC31/19/0511

Graft nephrectomy is associated with massive allo-sensitization following this event. The occurrence of anti-HLA antibodies is a major barrier to perform a second kidney transplantation. Investigators propose here to evaluate in a phase II pilot study, the safety of the use of a single dose of Tocilizumab immediately before or after graft nephrectomy. The primary endpoint evaluated here is the occurrence of serious infectious complications following graft nephrectomy, with a treatment by Tocilizumab. Secondary endpoints evaluated here are - to evaluate all complications after graft nephrectomy, - and the Tocilizumab effectiveness to reduce anti-HLA antibodies at one year post nephrectomy.

2021-10-01

2024-04-01

2024-04-01

Recruiting

Early phase I

18

Inclusion Criteria: * Adult recipients, * affiliated to the social security * requiring a graft nephrectomy, with a project to retransplantation Exclusion Criteria: * combined transplantations, PRA \>20%. * Patient under protective measures, * Rituximab used for immunosuppression induction * Previous transplants not removed, * Active infectious complications at graft nephrectomy, need for immunosuppressive treatments after graft nephrectomy, * Participation to another interventional studies using Rituximab, polyclonal antibodies, Eculizumab, or Tocilizumab. * adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision, * pregnancy or breastfeeding.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

2023-05-15