Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Lupus Nephritis, Immunoglobulin A Nephropathy

In brief

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

Key facts

Study ID

NCT04564339

Run by

Alexion Pharmaceuticals, Inc.

People needed

123

Starts

2021-01-19

Expected to finish

2025-08-18

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Common to both disease cohorts:
• Proteinuria ≥1 (gram [g]/day or g/g)
• Vaccinated against meningococcal infection
• Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements
• For LN cohort:
• Diagnosis of active focal or diffuse proliferative LN Class III or IV
• Clinically active LN, requiring/receiving immunosuppression induction treatment
• For IgAN cohort:
• Diagnosis of primary IgAN
• Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months

You may not qualify if…

• Common to both disease cohorts:
• eGFR < 30 milliliters/minute/1.73 meters squared
• Previously received a complement inhibitor (for example, eculizumab)
• Concomitant significant renal disease other than LN or IgAN
• History of other solid organ or bone marrow transplant
• Uncontrolled hypertension
• For IgAN cohort:
• Diagnosis of rapid progressive glomerulonephritis
• Prednisone or prednisone equivalent > 20 milligram (mg) per day for > 14 consecutive days or any other immunosuppression within 6 months

Where it is running

• Research Site — Santa Monica, California, United States
• Research Site — South Gate, California, United States
• Research Site — Stanford, California, United States
• Research Site — Orlando, Florida, United States
• Research Site — Plantation, Florida, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — El Paso, Texas, United States
• Research Site — Houston, Texas, United States
• Research Site — Herston, Australia
• Research Site — Parkville, Australia
• Research Site — Westmead, Australia
• Research Site — London, Ontario, Canada
• Research Site — Montreal, Quebec, Canada
• Research Site — Québec, Quebec, Canada
• Research Site — Clermont-Ferrand, France
• Research Site — Le Kremlin-Bicêtre, France
• Research Site — San Dimas, California, United States

Full record on ClinicalTrials.gov

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