CHU Toulouse
Toulouse, France
NCT Number: NCT04779957
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Toulouse, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.
Time frame: 1 year post graft nephrectomy
serious infectious complication rate at 1 year post graft nephrectomy
Time frame: 1 year post graft nephrectomy
Safety excluding serious infectious complications one year after nephrectomy, used by:
Time frame: 1 year post graft nephrectomy
The effectiveness of the treatment assessed by the rate of immunization after a post nephrectomy
University Hospital, Toulouse
Other
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
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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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