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

Anti-IL6 receptor antibodies to reduce allo-sensitization post allograft nephrectomy ; a pilot phase II study - RAIPONS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001087-28-FR

Enrollment

Registered

2020-10-23

Start date

2020-12-29

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney transplantation MedDRA version: 20.0 Level: PT Classification code 10029116 Term: Nephrectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: RoActemra Product Name: RoActemra Pharmaceutical Form: Solution for injection in administration system

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: the rate of serious infectious complication rate at 1 year post graft nephrectomy;Secondary Objective: Complications other than infectious complications, Occurrence of allo-sensitization at one year post graft nephrectomy;Primary end point(s): We hypothetize that Tocilizumab is usefull to prevent allo-sensitization post graft nephrectomy. We 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 infectious complications following early and late graft nephrectomy, with a treatment by Tocilizumab.;Timepoint(s) of evaluation of this end point: 1 year post graft nephrectomy	—

Measure

Time frame

Main Objective: the rate of serious infectious complication rate at 1 year post graft nephrectomy;Secondary Objective: Complications other than infectious complications, Occurrence of allo-sensitization at one year post graft nephrectomy;Primary end point(s): We hypothetize that Tocilizumab is usefull to prevent allo-sensitization post graft nephrectomy. We 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 infectious complications following early and late graft nephrectomy, with a treatment by Tocilizumab.;Timepoint(s) of evaluation of this end point: 1 year post graft nephrectomy

—

Secondary

Measure	Time frame
Secondary end point(s): Complications other than infectious complications, Occurrence of allo-sensitization at one year post graft nephrectomy;Timepoint(s) of evaluation of this end point: 1 year post graft nephrectomy	—

Countries

France

Contacts

Public ContactCLINICAL RESEARCH ASSISTANT

CHU Toulouse

daguzan.c@chu-toulouse.fr561778490+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026