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

NCT ID: NCT04779957

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-08-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Transplantation Graft Failure

Keywords

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Kidney transplantation allosensitization graft nephrectomy Donor-Specific Antibodies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tocilizumab

Evaluation of the use of Tocilizumab after allograft nephrectomy.

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.

Interventions

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Tocilizumab

Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud DEL BELLO, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC31/19/0511

Identifier Type: -

Identifier Source: org_study_id