VIB4920 for Active Lupus Nephritis
This study, called VIBRANT, is testing a drug called VIB4920 for people with active lupus nephritis (a kidney disease caused by lupus). You would continue taking your current medications, mycophenolate mofetil (MMF) and prednisone, while also receiving either VIB4920 or a placebo (an inactive substance). Researchers want to see if VIB4920 helps improve kidney function. The study aims to enroll 74 participants and is looking for adults aged 18 or older who have been diagnosed with Systemic Lupus Erythematosus (SLE) based on specific medical criteria. The main goal is to see how many participants achieve a complete kidney response by week 36.
- Study design
- This is a multi-center, double-blind (meaning neither you nor your doctor will know if you're receiving the study drug or placebo) study. About 74 participants will be randomly assigned to receive either VIB4920 or placebo.
- What's involved
- You would receive VIB4920 or placebo intravenously (through a vein) at specific weeks over 24 weeks. You would also receive methylprednisolone and continue taking MMF and prednisone, with prednisone tapering over time.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at Week 36, which suggests follow-up extends at least until this point after treatment begins.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
VIBRANT: VIB4920 for Active Lupus Nephritis
At a glance
Conditions
Where it's being run
17 sites across 11 statesStudy leadership
- Maria Dall'Era, M.D. · STUDY_CHAIR · University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
- Betty Diamond, M.D. · STUDY_CHAIR · Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
- David Wofsy, M.D. · STUDY_CHAIR · University of California San Francisco School of Medicine: Lupus Clinic and Rheumatology Clinical Research Center
Who to contact
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What this trial measures
- Proportion of participants achieving a complete renal response at week 36Week 36
Complete renal response is defined as all of the following: 1. Urine protein-to-creatinine ratio (UPCR) \<= 0.5, based on a 24-hour urine collection 2. Estimated glomerular filtration rate (eGFR) \>= 120 ml/min/1.73 m\^2 or, if \< 120 ml/min/1.73 m\^2, then \>= 80 percent of the eGFR at baseline 3. Prednisone \<= 5 mg/day from Week 8, according to the prednisone dosing restrictions