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New hope for kids with kidney disease: drug trial targets protein leak

NCT ID NCT07024563

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 4 times

Summary

This study tests a drug called ravulizumab in children aged 2 to 18 with a kidney disease called IgA nephropathy. The goal is to see if the drug can reduce protein in the urine, a sign of kidney damage. Participants will receive the drug through an IV and be monitored for safety and effectiveness over about 2 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis IgA nephropathy, susceptibility to, 1 immunoglobulin A vasculitis proteinuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Henoch-Schonlein purpura nephritis IgA vasculitis IGAN IGAVN Immunoglobulin A nephropathy Immunoglobulin A vasculitis associated nephritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research Site

    NOT_YET_RECRUITING

    Palo Alto, California, 94304, United States

  • Research Site

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Research Site

    RECRUITING

    Beijing, 100045, China

  • Research Site

    RECRUITING

    Shanghai, 201102, China

  • Research Site

    RECRUITING

    Genova, 16147, Italy

  • Research Site

    RECRUITING

    Roma, 00165, Italy

  • Research Site

    RECRUITING

    Torino, 10126, Italy

  • Research Site

    RECRUITING

    Wakayama, 641-8510, Japan

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    NOT_YET_RECRUITING

    Almería, 04009, Spain

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Barcelona, 8950, Spain

  • Research Site

    RECRUITING

    Seville, 41013, Spain

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

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