Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy
NCT04779957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-12-31
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
Interventions
- DRUG
-
Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.
Sponsors & Collaborators
-
University Hospital, Toulouse
lead OTHER
Principal Investigators
-
Arnaud DEL BELLO, MD · University Hospital, Toulouse
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-01
- Primary Completion
- 2024-08-09
- Completion
- 2024-08-09
Countries
- France
Study Locations
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