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.
Conditions:
🦠 Lupus Nephritis
🗓️ Study Start (Actual) 20 April 2021
🗓️ Primary Completion (Estimated) July 2026
✅ Study Completion (Estimated) July 2026
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Rochester, Minnesota, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 April 2021
  • First Submitted that Met QC Criteria 28 April 2021
  • First Posted 3 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 May 2024
  • Last Update Posted 6 May 2024
  • Last Verified May 2024