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

NCT04779957 | Completed Phase 2

• 1 other identifier: RC31/19/0511
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation; Graft Failure

Keywords

Kidney transplantation; allosensitization; graft nephrectomy; Donor-Specific Antibodies

Outcome Measures

Primary Outcomes (1)

• serious infectious complication

  serious infectious complication rate at 1 year post graft nephrectomy

  1 year post graft nephrectomy

Secondary Outcomes (2)

• Complications after treatment

  1 year post graft nephrectomy

• The effectiveness of the treatment

  1 year post graft nephrectomy

Study Arms (1)

Tocilizumab

EXPERIMENTAL

Evaluation of the use of Tocilizumab after allograft nephrectomy.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult recipients,
• affiliated to the social security
• requiring a graft nephrectomy, with a project to retransplantation

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Interventions

tocilizumab

Study Officials

• Arnaud DEL BELLO, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: October 1, 2021
• Primary Completion: August 9, 2024
• Study Completion: August 9, 2024
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

FR (1)