Ravulizumab: Participants will receive ravulizumab via weight-based intravenous (IV) infusion.
Placebo: Participants will receive placebo via weight-based IV infusion.
Study summary
The primary objective of this study to evaluate efficacy of ravulizumab compared with placebo on proteinuria reduction and change in eGFR in adult participants with IgAN who are at risk of disease progression.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Documentation of IgAN diagnosis established on kidney biopsy obtained any time prior to or during the Screening Period for participants with eGFR ≥ 30 mL/min/1.73 m\^2.
* For participants in the AdKD cohorts, eGFR 20 to 29 mL/min/1.73 m2 a kidney biopsy is required within 6 months prior to Screening or during the Screening Period.
* UPCR ≥ 0.75 g/g or UP ≥1 g/day calculated from the mean of two 24-hour urine during the Screening Period.
* Estimated GFR ≥ 30 mL/min/1.73 m2 at Screening.
* Stable and maximum allowed or tolerated RAASI (ACEI and/or ARB) dose for ≥ 3 months prior to Screening with no planned change during Screening through Week 106.
* Participants who are receiving SGLT2I, DEARA, MRA or ERA must be on a stable and maximum allowed or tolerated dose for ≥ 3 months prior to Screening with no planned change in dose through Week 106.
Exclusion Criteria:
* Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 50% over a period of 3 months prior to Screening.
* Secondary IgAN (eg, due to systemic lupus erythematosus (SLE), cirrhosis, or celiac disease; IgAV-N may be eligible).
* Concomitant clinically significant renal disease other than IgAN.
* Prior use of immunosuppressive treatment within 3 months of screening.
* Uncontrolled diabetes mellitus with glycosylated hemoglobin (HbA1c) \> 8.5%.
* Henoch-Schonlein purpura (IgAV) requiring systemic immunosuppressive therapy within 12 months of Screening.
* History of kidney transplant or planned kidney transplant during the Treatment Period.
* Splenectomy or functional asplenia.
* History of Neisseria meningitidis infection.
* Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
Primary outcome measure(s)
Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 — Baseline, Week 34 Evaluated at interim analysis only
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106 — Baseline, Week 106 Evaluated at final analysis only
Trial sites (246)
Facility
City
Region
Status
Research Site
Alabaster
Alabama
Research Site
Phoenix
Arizona
Research Site
Los Angeles
California
Research Site
Los Angeles
California
Research Site
Los Angeles
California
Research Site
Orange
California
Research Site
San Bernardino
California
Research Site
San Diego
California
Research Site
San Francisco
California
Research Site
Stanford
California
Research Site
Torrance
California
Research Site
Valencia
California
Research Site
Bay Pines
Florida
Research Site
Miami
Florida
Research Site
Orlando
Florida
Research Site
Acworth
Georgia
Research Site
Atlanta
Georgia
Research Site
Lawrenceville
Georgia
Research Site
New Orleans
Louisiana
Research Site
Boston
Massachusetts
Research Site
Boston
Massachusetts
Research Site
Boston
Massachusetts
Research Site
Worcester
Massachusetts
Research Site
Minneapolis
Minnesota
Research Site
Minneapolis
Minnesota
Research Site
Kansas City
Missouri
Research Site
North Las Vegas
Nevada
Research Site
Albany
New York
Research Site
New York
New York
Research Site
The Bronx
New York
Research Site
Columbus
Ohio
Research Site
Knoxville
Tennessee
Research Site
Arlington
Texas
Research Site
Houston
Texas
Research Site
Houston
Texas
Research Site
San Antonio
Texas
Research Site
Shenandoah
Texas
Research Site
Charlottesville
Virginia
Research Site
Milwaukee
Wisconsin
Research Site
Ciudad de Buenos Aires
Argentina
+ 206 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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