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

Trial ID or NCT#

NCT04564339

Status

recruiting iconRECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. Common to both disease cohorts:
    1. * 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
  2. For LN cohort:
    1. * Diagnosis of active focal or diffuse proliferative LN Class III or IV* Clinically active LN, requiring/receiving immunosuppression induction treatment
  3. For IgAN cohort:
    1. * Diagnosis of primary IgAN* Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months
Exclusion Criteria:
  1. Common to both disease cohorts:
    1. * 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
  2. For IgAN cohort:
    1. * 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
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Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)

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Contact

Shiktj Dave
650-723-2240

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View on ClinicalTrials.gov