Desensitization in Kidney Allograft Using Daratumumab

• Status: Recruiting
• Trial end date: 2022-11-29
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Janssen, LP
• Treatments: Antibodies, Monoclonal; Daratumumab

Criteria

Inclusion Criteria:

• Adults ≥ 18 years awaiting a kidney allograft transplantation

• Registration on the French National kidney allograft waiting-list for at least three years

• cPRA≥95% for at least three years

• Effective contraception up to three months after the end of treatment

• Informed consent obtained in accordance with local regulations

• Affiliation to a social security regime

Exclusion Criteria:

• Hypersensitivity to Daratumumab or to any of the excipients),

• Known allergy to methylprednisolone and its excipients or to diphenhydramine and its excipients or to acetaminophen and its excipients or to valacyclovir and its excipients.

• Severe hepatocellular insufficiency

• Psychotic state not yet controlled by treatment

• Patient refusal

• Pregnant or breastfeeding woman or ineffective contraception

• Active neoplasia

• Active infection

• Active HBV infection, including HBsAg positive at screening

• Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants

• Persons deprived of their liberty by judicial or administrative decision,

• Persons under legal protection/security safeguard of justice,

• Patients under duress psychiatric care,

• Persons admitted to a health or social institution

• Patient on AME (state medical aid)

• Contraindication to kidney transplantation