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

Trial ID or NCT#

NCT04564339

Status

not recruiting iconNOT RECRUITING

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

Investigator(s)

Richard Lafayette
Richard Lafayette
Nephrologist
Professor of Medicine (Nephrology)
Jackson Kim, MD
Jackson Kim, MD
Nephrologist
Clinical Assistant Professor, Medicine - Nephrology

Contact us to find out if this trial is right for you.

Contact

Shiktj Dave
650-723-2240