A Study to Assess the Effects of Zigakibart on IgA Nephropathy. (NCT07146906)
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).
Location: Colorado Kidney Care Nephrology — Denver, Colorado
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck 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).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- Colorado Kidney Care Nephrology — Denver, Colorado
- American Clinical Trials — Acworth, Georgia
- Univ Of Iowa Hospitals And Clinics — Iowa City, Iowa
- Inter Med Consultants — Edina, Minnesota
- Novartis Investigative Site — Serra, Espírito Santo
- Novartis Investigative Site — Recife, Pernambuco
- Novartis Investigative Site — Natal, Rio Grande do Norte
- Novartis Investigative Site — Botucatu, São Paulo
- Novartis Investigative Site — Beijing,
- Novartis Investigative Site — Shanghai,
- Novartis Investigative Site — Prague,
- Novartis Investigative Site — Munich, Bavaria
- Novartis Investigative Site — Hanover,
- Novartis Investigative Site — Mainz,
- Novartis Investigative Site — Ranica, BG
- Novartis Investigative Site — Brescia, BS
- Novartis Investigative Site — Pavia, PV
- Novartis Investigative Site — Kawasaki, Kanagawa
- Novartis Investigative Site — Miyazaki,
- Novartis Investigative Site — Lodz,
- Novartis Investigative Site — Opole,
- Novartis Investigative Site — Seoul, Seoul
- Novartis Investigative Site — Seoul,
- Novartis Investigative Site — Pamplona, Navarre
- Novartis Investigative Site — Valencia, Valencia
📞 Contact the Study Coordinator
Phone: (888) 669-6682
Email: novartis.email@novartis.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.