Daratumumab
Daratumumab is a monoclonal antibody directed at CD38, which depletes CD38 expressing plasma cells in the bone marrow and a cell-type-specific dysregulation of CD38 expression has been observed in patients with SLE.
Enroll in this clinical study
How is Daratumumab being studied in lupus nephritis?
The efficacy and safety of Daratumumab in the treatment of patients with active Lupus Nephritis is being studied in this phase 2 open-label single-group interventional study. The primary endpoint is the efficacy of daratumumab in inducing complete or partial renal remission in patients with active class III or IV Lupus Nephritis. Subjects diagnosed with lupus nephritis will receive Daratumumab 1800 mg administered by subcutaneous injection once weekly for 8 weeks and then once every 2 weeks for 8 additional doses (+/- 4 days). Subjects will be followed for a total of 24 months (18 months after the last daratumumab administration).
Eligibility Criteria
Age ≥ 18 years
Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12 months of enrolment.
Proteinuria ≥ 500 mg over 24 hours.
eGFR ≥ 30 ml/min/SA.