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New drug zigakibart aims to slow kidney disease in IgA nephropathy patients

NCT ID NCT07146906

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This study tests a drug called zigakibart in 32 adults with IgA nephropathy, a kidney disease. The goal is to see if it can reduce signs of kidney damage and slow disease progression. Participants must have a recent kidney biopsy and persistent protein in their urine despite standard care.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 32 people

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

Started

Mar 2026

Expected to finish

Oct 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

18 to 100 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: * Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening * eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening * Persistent proteinuria, defined as either * Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or * IgAN diagnosis \<6 months prior to Screening with Total Urine Protein \>1.5 g/day or UPCR \>1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis * Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening Exclusion Criteria: * Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder * Total IgG \<6.0 g/L at screening * Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections * An average systolic blood pressure \>150 mmHg or average diastolic blood pressure \>90 mmHg based on three measurements at Screening * Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening * Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening * Current treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors or past treatment of the same at any time for \>3 consecutive months prior to screening * Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis proteinuria

As listed by the trial registrant

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

Immunoglobulin A nephropathy (IGAN)

How to take part

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

  1. The places running it

    29 sites in 11 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • American Clinical Trials

    RECRUITING

    Acworth, Georgia, 30101, United States

  • Colorado Kidney Care Nephrology

    RECRUITING

    Denver, Colorado, 80230, United States

  • Inter Med Consultants

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Novartis Investigative Site

    RECRUITING

    Serra, Espírito Santo, 29160-750, Brazil

  • Novartis Investigative Site

    RECRUITING

    Recife, Pernambuco, 50740-900, Brazil

  • Novartis Investigative Site

    RECRUITING

    Natal, Rio Grande do Norte, 59012 300, Brazil

  • Novartis Investigative Site

    RECRUITING

    Botucatu, São Paulo, 3880-1001, Brazil

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100034, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200025, China

  • Novartis Investigative Site

    RECRUITING

    Prague, 128 08, Czechia

  • Novartis Investigative Site

    RECRUITING

    Munich, Bavaria, 81377, Germany

  • Novartis Investigative Site

    RECRUITING

    Hanover, 30625, Germany

  • Novartis Investigative Site

    RECRUITING

    Mainz, 55131, Germany

  • Novartis Investigative Site

    RECRUITING

    Ranica, BG, 24020, Italy

  • Novartis Investigative Site

    RECRUITING

    Brescia, BS, 25123, Italy

  • Novartis Investigative Site

    RECRUITING

    Pavia, PV, 27100, Italy

  • Novartis Investigative Site

    RECRUITING

    Kawasaki, Kanagawa, 213-8587, Japan

  • Novartis Investigative Site

    RECRUITING

    Miyazaki, 889-1692, Japan

  • Novartis Investigative Site

    RECRUITING

    Lodz, 92-213, Poland

  • Novartis Investigative Site

    RECRUITING

    Opole, 45-401, Poland

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03722, South Korea

  • Novartis Investigative Site

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    RECRUITING

    Valencia, Valencia, 46017, Spain

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    RECRUITING

    Seville, 41013, Spain

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 833, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Univ Of Iowa Hospitals And Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

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