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Evaluating Ravulizumab for Immunoglobulin A Nephropathy

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Immunoglobulin A Nephropathy (IgAN)

Phase 3 Interventional Alexion Pharmaceuticals, Inc. · NCT06291376

This study is testing if the medication ravulizumab can help adults with Immunoglobulin A Nephropathy reduce protein in their urine and improve kidney function compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment510 (estimated)
Ages18 Years and up
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsravulizumab
Locations267 sites (Alabaster, Alabama and 266 other locations)
Trial IDNCT06291376 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy of ravulizumab compared to a placebo in reducing proteinuria and improving estimated glomerular filtration rate (eGFR) in adults with Immunoglobulin A Nephropathy (IgAN) who are at high risk of disease progression. Approximately 510 participants will be enrolled, with around 450 randomized to receive either ravulizumab or placebo. Participants will be on stable concomitant IgAN treatments for at least three months prior to screening. The study includes an interim analysis at Week 34 and a final analysis at Week 106, with an option for participants to enter an Open-label Ravulizumab Access Period afterward.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with IgAN who have stable kidney function and are at high risk of disease progression.

Not a fit: Patients with rapid progressive glomerulonephritis or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and reduce proteinuria in patients with IgAN.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific application of ravulizumab in IgAN is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 RASI (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.

Where this trial is running

Alabaster, Alabama and 266 other locations

+217 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Immunoglobulin A NephropathyIgANImmunoglobulin A nephropathyproteinuriaglomerulonephropathychronic kidney diseaseCKD
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.