CompletedPhase 1/2

Desensitization in Kidney Allograft Using Daratumumab

France21 participantsStarted 2020-02-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * COVID-19 vaccination using Pfizer BioNtech vaccine for: Patients who have never been infected with COVID-19, inclusion at least one month after the third dose OR Patients previously infected with COVID-19 proved with PCR or serology, inclusion at least one month after the second injection of Pfizer BioNtech vaccine. * 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: * Refusal of COVID-19 vaccination using Pfizer BioNtech vaccine * 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…

What they're measuring

Serious adverse events (SAEs) and adverse event (AEs) related and unrelated to the treatment during the dose-escalation step

Timeframe: up to 21 months

Intra-patient variation of cPRA after daratumumab treatment

Timeframe: Baseline (Day 0) and at six months after daratumumab treatment

Trial details

NCT IDNCT04204980

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01