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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Graft Failure
• Intervention / Treatment: Drug: Tocilizumab

Detailed Description

Background: 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. Moreover, a systemic inflammatory response syndrome can occur which could lead to serious patient's complications, in case of early graft thrombosis. To date, no treatment or strategy is available to reduce these risks, after graft nephrectomy. IL-6 is a key cytokine in inflammation, but also in the development of T and B cells activation. This treatment previously demonstrated a major role in the occurrence of allo-antibodies. Tocilizumab is a monoclonal antibody blocking IL6 receptor, previously used with success in kidney transplantation to reduce anti-HLA antibodies mediated rejection.

Objectives: Investigators hypothesize that Tocilizumab is useful to prevent allo-sensitization post graft nephrectomy. They 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tocilizumab; Evaluation of the use of Tocilizumab after allograft nephrectomy.	Drug: Tocilizumab; Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serious infectious complication	serious infectious complication rate at 1 year post graft nephrectomy	1 year post graft nephrectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications after treatment	Safety excluding serious infectious complications one year after nephrectomy, used by: The occurrence of post-nephrectomy complications; The occurrence of death; The occurrence of hospitalizations; The occurrence of surgical complications; The occurrence of infectious complications (mild and moderate)	1 year post graft nephrectomy
The effectiveness of the treatment	The effectiveness of the treatment assessed by the rate of immunization after a post nephrectomy	1 year post graft nephrectomy

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Arnaud DEL BELLO, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): August 9, 2024
• Study Completion (Actual): August 9, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Kidney transplantation; allosensitization; graft nephrectomy; Donor-Specific Antibodies
• Additional Relevant MeSH Terms: tocilizumab
• Other Study ID Numbers: RC31/19/0511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No