Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
Trial ID or NCT#
NCT04564339
Status
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:
- 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Shiktj Dave
650-723-2240
View on ClinicalTrials.gov
