Overview

Desensitization in Kidney Allograft Using Daratumumab

Status:
Recruiting
Trial end date:
2022-11-29
Target enrollment:
Participant gender:
Summary
Patients highly allosensitized against HLA antigen awaiting for a kidney transplant have less compatible transplants to them, increasing their waitlist time and mortality. Current desensitization strategies need to be improved with a high remaining acute rejection rate in this population and a substantial survival benefit which is not uniformly reported in the literature. The investigators propose to use daratumumab, a human IgG1 (Immunoglobulin Gamma-1) monoclonal antibody directed against the CD38 molecule (cluster of differentiation 38) witch induce response in refractory multiple myeloma by depleting plasma cells, as a new agent of desensitization. The study will address the hypothesis that daratumumab can lead to a significant decrease in calculated panel reactive antibodies by elimination of anti-HLA antibodies-producing plasma cells and facilitate the access to transplantation with a safety profile in highly sensitized patients registered in our kidney transplantation center.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Janssen, LP
Treatments:
Antibodies, Monoclonal
Daratumumab