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

Sponsor
University Hospital, Toulouse
Study ID
NCT04779957
Phase
PHASE2
Status
Completed

Conditions

  • Graft Failure
  • Kidney Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Dec 2025
Primary completion
Aug 9, 2024
Completion
Aug 9, 2024

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Evaluation of the use of Tocilizumab after allograft nephrectomy.

Primary Outcome Measure

serious infectious complication [ Time Frame: 1 year post graft nephrectomy ]

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