Zigakibart treatment for IgA nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter, randomized Phase 2 study of zigakibart in participants with primary IgA nephropathy. Participants are assigned to one of two groups that differ only by when an on-treatment kidney biopsy is done: at the end of year one (Group A) or at the end of year two (Group B). The treatment period lasts 104 weeks, with a screening window and a 13-week safety follow-up for a total possible participation time of up to 125 weeks. Enrollment requires biopsy-confirmed primary IgAN, eGFR ≥45 mL/min/1.73 m2, and persistent proteinuria despite maximally tolerated supportive therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC San Francisco Medical Center
  San Francisco, California, United States Recruiting
• Colorado Kidney Care Nephrology
  Denver, Colorado, United States Recruiting
• American Clinical Trials
  Acworth, Georgia, United States Recruiting
• Univ Of Iowa Hospitals And Clinics
  Iowa City, Iowa, United States Recruiting
• Inter Med Consultants
  Edina, Minnesota, United States Recruiting
• Novartis Investigative Site
  Serra, Espírito Santo, Brazil Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How ARGX-121 affects protein in IgA nephropathy

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• ADX-038 with or without telitacicept for Chinese adults with IgA nephropathy, C3G, or IC-MPGN

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• Effects of Felzartamab on Adults with Immunoglobulin A Nephropathy

  This study is testing if felzartamab infusions can help adults with immunoglobulin A nephropathy reduce protein in their urine and improve kidney function.

  Recruiting at 251 sites Phase 3 Biogen · Little Rock, Arkansas and 264 other locations · NCT06935357

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.