RecruitingPhase 3NCT06858319

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

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

Sponsor

Novartis Pharmaceuticals

Enrollment

220 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

Kidney Diseases Kidney Diseases, Chronic Urological Diseases Glomerulonephritis Glomerular Disease Glomerulonephritis, IGA Glomerulopathy Immunoglobulin Disease

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This open-label extension study allows patients who completed a parent clinical trial of zigakibart — an experimental drug for IgA nephropathy (a kidney disease caused by immune deposits) — to continue receiving the drug long-term to assess ongoing safety and benefit. **You may be eligible if...** - You completed the full treatment period in a parent zigakibart clinical trial for IgA nephropathy - Your doctor believes you may still benefit from continued treatment **You may NOT be eligible if...** - You withdrew early from the parent study for any reason - You have been on dialysis for 30+ days or need a kidney transplant - You have had an acute kidney injury within the past 4 weeks - You have rapidly progressive kidney inflammation (RPGN) or another new kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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