Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around
Principal Investigator
by Anjay Rastogi

Description

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).

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)

Details

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Keywords

Lupus Nephritis, Immunoglobulin A Nephropathy, glomerulonephritis, IGA, complement C5, Kidney Diseases, Nephritis, IGA Glomerulonephritis, Ravulizumab, Background Therapy

Eligibility

You can join if…

Open to people ages 18-75

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 CAN'T join 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

Locations

  • Research Site accepting new patients
    Santa Monica California 90404 United States
  • Research Site accepting new patients
    Los Angeles California 90027 United States
  • Research Site accepting new patients
    S. Gate California 90280 United States

Lead Scientist at UCLA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alexion Pharmaceuticals, Inc.
ID
NCT04564339
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated