Anti-IL6 receptor antibodies to reduce allo-sensitization post allograft nephrectomy

Phase 1

• Conditions: kidney transplantation; Therapeutic area: Body processes [G] - Immune system processes [G12]; MedDRA version: 20.0Level: PTClassification code 10029116Term: NephrectomySystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2020-001087-28-FR
• Lead Sponsor: CHU Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-23
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Adult recipients, affiliated to the social security, requiring a graft nephrectomy, with a project to retransplantation
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 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified