Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse

Criteria

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, Eucizumab, or Tocilizumab.

• adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision,

• pregnancy or breastfeeding.