Daratumumab to Treat Active Lupus Nephritis

Mayo Clinic

Status and phase: Active, not recruiting; Phase 2

Conditions: Lupus Nephritis

Treatments: Drug: Daratumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04868838

20-010520

Details and patient eligibility

About

The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years of age.
• Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria.
• 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 enrollment.
• Proteinuria ≥ 500 mg over 24 hours.
• eGFR ≥ 30 ml/min/SA.
• Subjects should be able to give informed consent.

Exclusion criteria

• Pregnancy.
• Hepatitis B or C, HIV
• Anemia with Hgb < 8.0 g/dL.
• Thrombocytopenia with platelet count < 100'000.
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complication.
• Unable to provide consent.
• Patients receiving > 10 mg of oral prednisone or glucocorticoid equivalent if on corticosteroids for > 2 weeks (patients would be allowed to be on > 10 mg of prednisone or its oral equivalent as long as the duration is ≤ 2 weeks).
• Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus or azathioprine in the last 3 months.
• Patients who have received cyclophosphamide in the last 6 months.
• Patients who received rituximab previously with CD20 count of zero at the time of enrollment.
• Patient are allowed to be on MMF at time of enrollment but no higher than total of 1500mg/day.
• For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (<) 1 percent (%) per year, during the treatment period and for at least 12 months after the last dose of study drug.
• For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period.
• Patients with diagnosis of glaucoma.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Daratumumab

Experimental group

Description:

Subjects diagnosed with lupus nephritis will receive Daratumumab once weekly for 8 weeks and then once every 2 weeks for 8 additional does (+/- 4 days). Subjects will be followed for a total of 24 months (18 months after the last daratumumab administration).

Treatment:

Drug: Daratumumab