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NCT07146906PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

3/26/2026

Completion Date

10/18/2030

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).

Eligibility Criteria

Age Range: 18 years to 100 years

Inclusion Criteria: * Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening * eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening * Persistent proteinuria, defined as either * Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or * IgAN diagnosis \<6 months prior to Screening with Total Urine Protein \>1.5 g/day or UPCR \>1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis * Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening 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.

Interventions

BIOLOGICAL

zigakibart

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Conditions

Immunoglobulin A Nephropathy (IgAN)

Locations

Colorado Kidney Care Nephrology

Denver, Colorado 80230

United States

American Clinical Trials

Acworth, Georgia 30101

United States

Univ Of Iowa Hospitals And Clinics

Iowa City, Iowa 52242

United States

Inter Med Consultants

Edina, Minnesota 55435

United States

Novartis Investigative Site

Serra, Espírito Santo 29160-750

Brazil

Novartis Investigative Site

Botucatu, São Paulo 3880-1001

Brazil

Novartis Investigative Site

Beijing, 100034

China

Novartis Investigative Site

Shanghai, 200025

China

Novartis Investigative Site

Munich, Bavaria 81377

Germany

Novartis Investigative Site

Hanover, 30625

Germany

Novartis Investigative Site

Mainz, 55131

Germany

Novartis Investigative Site

Ranica, BG 24020

Italy

Novartis Investigative Site

Brescia, BS 25123

Italy

Novartis Investigative Site

Pavia, PV 27100

Italy

Novartis Investigative Site

Kawasaki, Kanagawa 213-8587

Japan

Novartis Investigative Site

Miyazaki, 889-1692

Japan

Novartis Investigative Site

Lodz, 92-213

Poland

Novartis Investigative Site

Opole, 45-401

Poland

Novartis Investigative Site

Seoul, Seoul 03080

South Korea

Novartis Investigative Site

Seoul, 03722

South Korea

Novartis Investigative Site

Pamplona, Navarre 31008

Spain

Novartis Investigative Site

Valencia, Valencia 46017

Spain

Novartis Investigative Site

Barcelona, 08036

Spain

Novartis Investigative Site

Seville, 41013

Spain

Novartis Investigative Site

Kaohsiung City, 83301

Taiwan

Novartis Investigative Site

Taipei, 10002

Taiwan