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Study of Ravulizumab in Children with IgA Nephropathy

This study is looking at ravulizumab, given through an IV, in children aged 2 to under 18 years old who have IgA Nephropathy (IgAN) or IgA Vasculitis Associated Nephritis (IgAVN). These are kidney conditions. The main goals are to understand how ravulizumab works in the body, its safety, and how well it reduces protein in the urine. To join, you must be 2 to under 18 years old, be on a stable dose of certain blood pressure medications for at least 3 months, and have a specific level of protein in your urine. The study will measure changes in protein in the urine at Week 34. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 36 participants. The phase of the study is not specified.
What's involved
Participants will receive ravulizumab through intravenous (IV) infusions. Protein in the urine will be measured at the start of the study and again at Week 34.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 34. There is a mention of no planned change in medication through Week 106, which may indicate a longer follow-up period.

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NCT07024563

Study of Ravulizumab in Pediatric Participants With Primary IgAN

Recruiting
PHASE3Ages 2–18InterventionalTreatment
Alexion Pharmaceuticals, Inc.
~36 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Ravulizumab

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34
Measured over Baseline, Week 34

Conditions

IgAN
IgAVN
Immunoglobulin A Nephropathy
Immunoglobulin A Vasculitis Associated Nephritis
Henoch-schonlein Purpura Nephritis
IgA Vasculitis

Explore related trials

IgA NephropathyImmunoglobulin A Vasculitis Associated Nephritis

Where it's being run

15 sites across 8 states
Spain4
Italy3
China2
Taiwan2
California1
Colorado1
Japan1
South Korea1

Who to contact

Alexion Pharmaceuticals, Inc. (Sponsor)
[email protected]
1-855-752-2356
Email the study team

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Eligibility criteria

Inclusion

Participant must be 2 to \< 18 years of age at the time of signing the informed consent or assent.
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.
UPCR ≥ 1.0 g/g from the mean of 3 first morning voids (FMV) collected within 1 week during the Screening Period
Estimated GFR ≥ 30 mL/min/1.73 m2 during Screening
Meningococcal infection vaccine
Haemophilus influenzae type b and Streptococcus pneumoniae vaccine
Participants who are receiving SGLT2i, DEARA (eg, sparsentan), MRA, ERA, or GLP-1 agonists 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 34.
Established diagnosis of primary IgAN diagnosis based on kidney biopsy within 3 years prior to Screening or during the Screening Period

Exclusion

Diagnosis of rapidly progressive glomerulonephritis
Secondary forms of IgAN not in the context of primary IgAN or IgAV
Concomitant clinically significant renal disease other than IgAN or IgAVN
Clinical remission of IgAN/IgAVN or clinically significant improvement in proteinuria within the last 6 months.
Uncontrolled diabetes mellitus with HbA1c \> 8.5%
History of kidney transplant or planned kidney transplant during the Primary Evaluation Period.
History of other solid organ (heart, lung, small bowel, pancreas, or liver) or bone marrow transplant
Splenectomy or functional asplenia
Participants with nephrotic syndrome receiving albumin infusions or with acute kidney injury requiring dialysis within the last 6 months prior to Screening.
Hemolytic uremic syndrome diagnosed any time prior to Screening.
Planned urological surgery expected to influence kidney function within the study time frame.
Congenital immunodeficiency
Active systemic bacterial, viral, or fungal infection within 14 days prior to enrollment
Received biologics for the treatment of IgAN or IgAVN within≤ 6 months prior to Screening

What this trial measures

  • Change from Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR) at Week 34Baseline, Week 34