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Completed

NCT Number: NCT04779957

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Toulouse

Toulouse, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tocilizumab

Drug

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

Primary outcomes

  1. serious infectious complication

    Time frame: 1 year post graft nephrectomy

    serious infectious complication rate at 1 year post graft nephrectomy

Secondary outcomes

  1. Complications after treatment

    Time frame: 1 year post graft nephrectomy

    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)
  2. The effectiveness of the treatment

    Time frame: 1 year post graft nephrectomy

    The effectiveness of the treatment assessed by the rate of immunization after a post nephrectomy

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: RAIPONS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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