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

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Trial ID: NCT04564339

Purpose

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).

Official Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

Stanford Investigator(s)

Richard Lafayette
Richard Lafayette

Professor of Medicine (Nephrology)

Eligibility


Inclusion Criteria:

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

Exclusion Criteria:

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

Intervention(s):

drug: Ravulizumab

drug: Placebo

other: Background Therapy

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shiktj Dave
650-723-2240