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A Study of Zigakibart for IgA Nephropathy

This study is looking at how a medicine called zigakibart affects Immunoglobulin A Nephropathy (IgAN), a kidney disease. You might be able to join if you are 18 to 100 years old, have IgAN confirmed by a kidney biopsy within the last 5 years, and have certain levels of kidney function (eGFR) and protein in your urine. The study will give zigakibart 600 mg as injections every two weeks for two years. Researchers will measure changes in IgA deposits in your kidneys after one or two years of treatment to see if zigakibart is effective. The study is currently unclear on its recruitment status and plans to enroll 32 participants.

Study design
This is an open-label study, meaning both you and the study team will know you are receiving zigakibart. Participants are randomly assigned to one of two groups, differing only in when a follow-up kidney biopsy is performed. The study plans to enroll 32 participants.
What's involved
You would receive zigakibart injections every two weeks for 104 weeks (2 years). Your total participation could last up to 125 weeks, including screening, treatment, and a safety follow-up period.
Compensation
Not stated in the trial record.
Follow-up
After the 104-week treatment period, there is a safety follow-up period of 13 weeks. The primary endpoint measures changes in IgA deposition at Week 53 or Week 105.

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

NCT07146906

A Study to Assess the Effects of Zigakibart on IgA Nephropathy.

Recruiting
PHASE2Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~32 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:zigakibart

At a glance

Recruiting sites
29 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mesangial IgA deposition
Measured over Baseline to Week 53 or 105

Conditions

Immunoglobulin A Nephropathy (IgAN)

Explore related trials

IgA Nephropathy

Where it's being run

29 sites across 24 states
China2
Germany2
Poland2
Spain2
Taiwan2
Colorado1
Georgia1
Iowa1

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in mesangial IgA depositionBaseline to Week 53 or 105

    Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining