Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

This study is testing ravulizumab, a medication given through an IV, against a placebo (an inactive substance) in adults with Immunoglobulin A Nephropathy (IgAN), a kidney disease. The goal is to see if ravulizumab can reduce protein in your urine and improve how well your kidneys filter waste. You may be able to join if you are 18 or older, have a confirmed IgAN diagnosis from a kidney biopsy, and meet certain kidney function (eGFR) and urine protein (UPCR) levels. The study is currently recruiting about 579 participants. Researchers will measure changes in your urine protein at Week 34 and your kidney function at Week 106 to see if ravulizumab is effective.

Study design: This interventional study plans to enroll about 579 participants. Approximately 450 participants will be randomly assigned to receive either ravulizumab or a placebo, both given as IV infusions.
What's involved: Participants will receive weight-based IV infusions of either ravulizumab or placebo. Your proteinuria will be measured at Week 34 and your kidney function (eGFR) at Week 106.
Compensation: Not stated in the trial record.
Follow-up: The final analysis to evaluate kidney function (eGFR) will be conducted at Week 106. After Week 106, all participants have the option to enter an Open-label Ravulizumab Access Period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

Active, Not Recruiting

PHASE3Ages 18+InterventionalTreatment

Alexion Pharmaceuticals, Inc.

~579 participants

Updated 2026-06-22 on ClinicalTrials.gov

What's tested:RavulizumabPlacebo

At a glance

Recruiting sites

0 of 246 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34

Measured over Baseline, Week 34

+1 more outcome measured

Conditions

Immunoglobulin A Nephropathy

IgAN

Where it's being run

246 sites across 44 states

China35

Japan15

France12

Italy12

Spain11

California10

Brazil10

Germany10

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34Baseline, Week 34
Evaluated at interim analysis only
Change from Baseline in Glomerular Filtration Rate (eGFR) at Week 106Baseline, Week 106
Evaluated at final analysis only

Trialytics