NCT07146906

A Study to Assess the Effects of Zigakibart on IgA Nephropathy.

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.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.

Detailed description

This is an open-label multicenter study where participants are randomized into one of two groups, where the only difference between the groups is the on-treatment biopsy time point, end of the first year of treatment (Group A) or at the end of the second year of treatment (Group B). The total study duration for each participant may be up to 125 weeks, including the maximum screening period (8 weeks), the treatment period (104 weeks), and the safety follow up period (13 weeks).

Conditions

• Immunoglobulin A Nephropathy (IgAN)

Interventions

Type	Name	Description
BIOLOGICAL	zigakibart	zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

Timeline

• Start date: 2026-03-26
• Primary completion: 2030-07-12
• Completion: 2030-10-18
• First posted: 2025-08-28
• Last updated: 2026-04-01

Locations

8 sites across 5 countries: United States, China, Japan, South Korea, Taiwan

Regulatory

• FDA-regulated drug study