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Active, Not Recruiting

NCT Number: NCT04868838

Daratumumab to Treat Active Lupus Nephritis

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 12 months after first infusion of Daratumumab

    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

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

    Time frame: 12 months after first infusion of Daratumumab

    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

Secondary outcomes

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

    Time frame: 24 months after first infusion of Daratumumab

    Incidence of major infections defined in the development of pneumonia, grade 3 urinary tract infection/pyelonephritis, sepsis, meningitis or anemia.

  2. Improvement from proteinuria

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

    Change in proteinuria in milligrams (mg) per 24h

  3. Change in hematuria.

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

    Improvement in hematuria from baseline as measured by the urinalysis

  4. Improvement in eGFR

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

    Improvement in eGFR measured using the chronic kidney disease epidemiology collaboration (CKD-EPI) Equation: eGFR (CKD-EPI) = 141 x min(Scr/k, 1)alpha x max(Scr/k,1)-1.209 x 0.993age x 1.018 (if patient is female) x 1.159 (if patient is black)

  5. Change in ds-DNA

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

    Improvement in ds-DNA in International units per milliliter (IU/mL)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Phase 2 Open-label Trial Evaluating the Efficacy and Safety of Daratumumab in Treatment of Patients With Active Lupus Nephritis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 3, 2021
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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