🏛️ Verified NIH Record • Updated 2026-08-14

Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. (NCT06858319)

A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Novartis Pharmaceuticals

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (23 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 Checklist

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).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
  • Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.
  • Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
  • Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.
  • Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.
  • Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for \> 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.
  • Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.
  • Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction \[PCR\] will be allowed), or antibodies to HIV-1 and/or HIV-2.
  • Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are eligible for the study).
  • Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
  • History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.

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

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

  • Colorado Kidney Care Nephrology — Denver, Colorado
  • Nephrology Associates Of Central FL — Orlando, Florida
  • University of Iowa Hospitals and Clinics — Iowa City, Iowa
  • NY Nephrology — Clifton Park, New York
  • Icahn School of Medicine at Mount Sinai — New York, New York
  • Knoxville Kidney Center Pllc — Brentwood, Tennessee
  • Dallas Renal Group — Dallas, Texas
  • Dallas Renal Group — Dallas, Texas
  • Nephro Asso North Illinois Indiana — Houston, Texas
  • Novartis Investigative Site — Caba, Buenos Aires
  • Novartis Investigative Site — La Plata, Buenos Aires
  • Novartis Investigative Site — Buenos Aires, Buenos Aires F.D.
  • Novartis Investigative Site — Catamarca, Catamarca Province
  • Novartis Investigative Site — Santa Fe,
  • Novartis Investigative Site — Gosford, New South Wales
  • Novartis Investigative Site — Kogarah, New South Wales
  • Novartis Investigative Site — Toronto, Ontario
  • Novartis Investigative Site — Kuantan, Pahang
  • Novartis Investigative Site — Kuala Lumpur,
  • Novartis Investigative Site — Monterrey, Nuevo León
  • Novartis Investigative Site — Cheonan, Chungcheongnam-do
  • Novartis Investigative Site — Guri-si, Gyeonggi-do
  • Novartis Investigative Site — Seongnam-si, Gyeonggi-do
  • Novartis Investigative Site — Seoul, Seoul
  • Novartis Investigative Site — Girona, Catalonia

📞 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.

More studies in Kidney Diseases

Explore by condition: All Kidney Diseases clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
🏛️ View Official NIH Record ↗