A Study of Zigakibart in Adults With IgA Nephropathy

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: IgA Nephropathy, Immunoglobulin A Nephropathy

In brief

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Key facts

Study ID

NCT05852938

Run by

Novartis Pharmaceuticals

People needed

383

Starts

2023-07-06

Expected to finish

2028-01-25

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
• Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
• eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
• Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
• Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.

You may not qualify if…

• Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
• Diagnosis of IgA Vasculitis.
• Current or history of nephrotic syndrome.
• Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for > 14 days within 12 weeks prior to Screening.
• Use of systemic immunosuppressant medications.
• IgG levels < 6 g/L at Screening.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Paris, France
• University of Alabama at Birmingham: The Kirklin Clinic — Birmingham, Alabama, United States
• Nephrology Consultants, LLC — Huntsville, Alabama, United States
• University of California, San Francisco — San Francisco, California, United States
• Valiance Clinical Research — South Gate, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Nephrology Research Division — Denver, Colorado, United States
• Vida Medical Centers - Pembroke Pines — Pembroke Pines, Florida, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Nephrology Associales of Northern Illinois and Indiana — Hinsdale, Illinois, United States
• Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd — Fort Wayne, Indiana, United States
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States
• Intermed Consultants — Edina, Minnesota, United States
• Capital District Renal Physicians — Clifton Park, New York, United States
• Nephrology Associates PC - Flushing — Flushing, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• University of Cincinnati College of Medicine - 231 Albert Sabin Way — Cincinnati, Ohio, United States
• Cleveland Clinic-9500 Euclid Ave — Cleveland, Ohio, United States
• OHSU - Oregon Clinical and Translational Research Institute — Portland, Oregon, United States
• Northeast Clinical Research Center, LLC — Bethlehem, Pennsylvania, United States
• Columbia Nephrology Associates , P.A. - Columbia — Columbia, South Carolina, United States
• Knoxville Kidney Center, PLLC - Frenova F1 — Knoxville, Tennessee, United States
• Dallas Renal Group - 1411 N Beckley Ave — Dallas, Texas, United States
• Dallas Renal Group - Waxachie - 2460 N. I-35 — Dallas, Texas, United States
• Novartis Investigative Site — Paris, France

Full record on ClinicalTrials.gov

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