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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04779957
Other study ID # RC31/19/0511
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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