Desensitization in Kidney Allograft Using Daratumumab

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

February 18, 2020

Primary Completion Date

June 1, 2023

Study Completion Date

June 1, 2023

Conditions
AllosensitizationKidney Transplant RejectionAntibody-mediated Rejection
Interventions
DRUG

Daratumumab dose escalation

\- Step I: dose-escalation 3 patients treated weekly during four weeks with 4 mg/kg of daratumumab, then 3 patients treated weekly during four weeks with 8 mg/kg of daratumumab, then 3 patients treated weekly four weeks with 16 mg/kg of daratumumab

DRUG

Daratumumab full dose

\- Step II: expansion cohort to 13 patients (with 10 new patients included and the last 3 patients from the step I) with eight weekly doses of 16 mg/kg daratumumab

Trial Locations (1)

94000

Henri Mondor, Créteil

All Listed Sponsors
collaborator

Janssen, LP

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT04204980 - Desensitization in Kidney Allograft Using Daratumumab | Biotech Hunter | Biotech Hunter