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Clinical Trials in the USA / NCT06291376
Active, not recruiting Phase 3

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

NCT06291376 · tracked via the Priya Life Science USA tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 3
Started
2024-03-29
Last updated
2026-06-22

Condition(s) studied

Immunoglobulin A NephropathyIgAN

Investigational drug(s) / intervention(s)

RavulizumabPlacebo

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)

Trial sites (246)

FacilityCityRegionStatus
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.

On this site

📄 Ultomiris (ravulizumab) drug profile →

More Alexion Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT06291376 on ClinicalTrials.gov ↗ ← All trials in the USA