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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult recipients,

• affiliated to the social security

• requiring a graft nephrectomy, with a project to retransplantation

Locations
Other Locations
France
CHU Toulouse
RECRUITING
Toulouse
Contact Information
Primary
Arnaud DEL BELLO, MD
delbello.a@chu-toulouse.fr
0561323923
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2024-10
Participants
Target number of participants: 18
Treatments
Experimental: Tocilizumab
Evaluation of the use of Tocilizumab after allograft nephrectomy.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov