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

About

Brief Summary

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).

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
75 Years

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

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Study Stats
Protocol No.
21-000778
Category
Autoimmune Disorders
Contact
Jordan Ziegler
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04564339
For detailed technical eligibility, visit ClinicalTrials.gov.