NCT06858319

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a non-randomized, multicenter, open-label extension (OLE) study to Phase 3, randomized CHK02-02 (CFUB523A12301)-BEYOND clinical study, Phase 1/2 ADU-CL-19 (CFUB523A12103) clinical study, and any other Novartis-sponsored clinical study of zigakibart in IgAN.

Conditions

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

Interventions

Type	Name	Description
DRUG	zigakibart	solution for subcutaneous injection

Timeline

• Start date: 2025-07-28
• Primary completion: 2031-06-25
• Completion: 2031-06-25
• First posted: 2025-03-05
• Last updated: 2026-02-06

Locations

6 sites across 3 countries: United States, Argentina, South Korea

Regulatory

• FDA-regulated drug study