Daratumumab to Treat Active Lupus Nephritis

• Status: Recruiting
• Trial end date: 2023-09-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Daratumumab

Criteria

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.