A Study of Zigakibart in Adults With IgA Nephropathy (NCT05852938)

🧪 Interventions in This Study

• BION-1301 (DRUG)
• Placebo (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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.
2. 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.
3. eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
4. 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.
5. 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (200 Sites)

Showing the first 25 of 200 sites.

• University of Alabama at Birmingham: The Kirklin Clinic — Birmingham, Alabama
• Nephrology Consultants, LLC — Huntsville, Alabama
• University of California, San Francisco — San Francisco, California
• Valiance Clinical Research — South Gate, California
• University of Colorado Hospital — Aurora, Colorado
• Denver Nephrology Research Division — Denver, Colorado
• Vida Medical Centers - Pembroke Pines — Pembroke Pines, Florida
• NorthShore University HealthSystem — Evanston, Illinois
• Nephrology Associales of Northern Illinois and Indiana — Hinsdale, Illinois
• Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd — Fort Wayne, Indiana
• University Of Iowa Hospitals And Clinics — Iowa City, Iowa
• Intermed Consultants — Edina, Minnesota
• Capital District Renal Physicians — Clifton Park, New York
• Nephrology Associates PC - Flushing — Flushing, New York
• Icahn School of Medicine at Mount Sinai — New York, New York
• University of Cincinnati College of Medicine - 231 Albert Sabin Way — Cincinnati, Ohio
• Cleveland Clinic-9500 Euclid Ave — Cleveland, Ohio
• OHSU - Oregon Clinical and Translational Research Institute — Portland, Oregon
• Northeast Clinical Research Center, LLC — Bethlehem, Pennsylvania
• Columbia Nephrology Associates , P.A. - Columbia — Columbia, South Carolina
• Knoxville Kidney Center, PLLC - Frenova F1 — Knoxville, Tennessee
• Dallas Renal Group - 1411 N Beckley Ave — Dallas, Texas
• Dallas Renal Group - Waxachie - 2460 N. I-35 — Dallas, Texas
• DaVita Clinical Research — El Paso, Texas
• University of Texas MD Anderson Cancer Center-1155 Pressler — Houston, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in IgA Nephropathy

• A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G — Lawrenceville, Georgia
• Study of BHV-1400 in IgA Nephropathy — Farmington, Connecticut
• Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue — Denver, Colorado
• Atrasentan in Patients With IgA Nephropathy — Birmingham, Alabama
• Atrasentan in Patients With Proteinuric Glomerular Diseases — Glendale, California

Explore by condition: All IgA Nephropathy clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.