Daratumumab to Treat Active Lupus Nephritis

NCT04868838 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20-010520
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (2)

• Efficacy of daratumumab in inducing complete(CR) or partial(PR) renal remission in patients with active class III or IV Lupus Nephritis

  Complete Renal Response:- \< 500 mg proteinuria/24 hours, Inactive urinary sediment (\<10 RBC/HPF and absence of RBC casts), No greater than a 15% reduction in eGFR from enrollment

  12 months after first infusion of Daratumumab

• Efficacy of daratumumab in inducing complete(CR) or partial(PR)

  Partial Renal Response: \> 50% reduction in 24-hour proteinuria and proteinuria \< 1g/24hr if baseline 24hr proteinuria, - ≤3 g/24hr and proteinuria ≤ 3 g/24hr if starting proteinuria \> 3 g/24hrs. , Improved urinary sediment (\>=50% reduction in RBC/HPF and absence of RBC casts), No greater than a 20% reduction in baseline eGFR

  12 months after first infusion of Daratumumab

Secondary Outcomes (5)

• Safety of daratumumab in patients with active class III/IV LN.

  24 months after first infusion of Daratumumab

• Improvement from proteinuria

  Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab

• Change in hematuria.

  Baseline,6, 12, 18 and 24 months after first infusion of Daratumumab

• Improvement in eGFR

  Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab

• Change in ds-DNA

  Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab

Study Arms (1)

Daratumumab

EXPERIMENTAL

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).

Drug: Daratumumab

Interventions

Daratumumab DRUG

1800 mg administered by subcutaneous injection by manual push over approximately 3-5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses.

Daratumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lupus Nephritis

Interventions

daratumumab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fernando Fervenza, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 3, 2021
• Study Start: April 20, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)