drugset / Trial / NCT04204980

Desensitization in Kidney Allograft Using Daratumumab

NCT04204980

NaSequentialOpen-labelTreatment

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.

Timeline

Start
2020-02-18
Primary completion
2023-06-01
Completion
2023-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Daratumumab Monoclonal antibody 4 mg/kg
Subject Daratumumab Monoclonal antibody 8 mg/kg
Subject Daratumumab Monoclonal antibody 16 mg/kg