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

Kidney Transplantation Clinical Trial

— RAIPONS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779957
• Other study ID #: RC31/19/0511
• Status: Recruiting
• Phase: Phase 2
• Start date: October 1, 2021
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: Arnaud DEL BELLO, MD
• Phone: 0561323923
• Email: delbello.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graft Failure
• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serious infectious complication	serious infectious complication rate at 1 year post graft nephrectomy	1 year post graft nephrectomy
Secondary	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
Secondary	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