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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Recruiting

CT.gov ID

NCT04779957

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Graft Failure	Drug: Tocilizumab	Phase 2

Detailed 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 hypothetize that Tocilizumab is usefull 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluation of the Safety of Use of Anti-IL6 Receptor Antibodies to Reduce Allo-sensitization Post Allograft Nephrectomy ; a Pilot Phase II Study.

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tocilizumab Evaluation of the use of Tocilizumab after allograft nephrectomy.	Drug: Tocilizumab Tocilizumab will be administered at 8 mg/kg before or immediately after graft nephrectomy.

Arm

Intervention/Treatment

Experimental: Tocilizumab

Evaluation of the use of Tocilizumab after allograft nephrectomy.

Drug: Tocilizumab

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

Outcome Measures

Primary Outcome Measures

serious infectious complication [1 year post graft nephrectomy]
serious infectious complication rate at 1 year post graft nephrectomy

Secondary Outcome Measures

Complications after treatment [1 year post graft nephrectomy]
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)
The effectiveness of the treatment [1 year post graft nephrectomy]
-The effectiveness of the treatmentassessed by the rate of immunization after a post nephrectomy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, Eucizumab, or Tocilizumab.
adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision,
pregnancy or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Toulouse	Toulouse		France

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

Principal Investigator: Arnaud DEL BELLO, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT04779957

Other Study ID Numbers:

RC31/19/0511

First Posted:

Mar 3, 2021

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Kidney transplantation

allosensitization

graft nephrectomy

Donor-Specific Antibodies

Study Results

No Results Posted as of Mar 31, 2022