A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy

NCT07850752 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CFUB523A12303
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase IIIb, multicenter, two-arm, randomized, double-blind, parallel group study to evaluate the efficacy and safety of zigakibart + atrasentan compared to zigakibart + placebo in patients with primary IgAN at risk of disease progression.

Conditions

IgA Nephropathy (IgAN)

Keywords

Zigakibart; Atrasentan; IgA nephropathy; IgAN; Proteinuria; UPCR; eGFR; eGFR slope; Kidney function decline

Outcome Measures

Primary Outcomes (1)

• Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection

  Relative difference between treatment groups in mean change of natural log 24-hour UPCR from Baseline to Week 36, expressed as percent reduction

  Baseline, Week 36

Secondary Outcomes (5)

• Rate of patients achieving proteinuria remission at Week 52

  Week 52

• Rate of proteinuria remission

  Week 52

• Proportion of participants with AEs, SAEs and AESIs

  128 Weeks

• Change from baseline in Glomerular Filtration rate (GFR)

  Baseline and up to 104 weeks

• Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

  Baseline and up to 104 weeks

Study Arms (2)

zigakibart + atrasentan

EXPERIMENTAL

Patients receive zigakibart and atrasentan

Biological: zigakibart; Drug: atrasentan

zigakibart + placebo

ACTIVE COMPARATOR

Patients receive zigakibart and matching placebo

Biological: zigakibart; Drug: Placebo

Interventions

zigakibart BIOLOGICAL

Solution for injection via PFS-NSD

Also known as: BION-1301, FUB523

zigakibart + atrasentan; zigakibart + placebo

atrasentan DRUG

Tablet

Also known as: CHK01, EXV811

zigakibart + atrasentan

Placebo DRUG

Tablet

zigakibart + placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years at the time of signing the informed consent, prior to initiation of any study specific activities/procedures
• Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. If a biopsy report within 10 years is not available, re-biopsy may be performed locally during Screening.
• eGFR ≥ 30 mL/min/1.73m2 by a central laboratory at Screening, calculated using serum creatinine based on the 2021 CKD-EPI equation (Inker et al 2021)
• UPCR ≥ 0.7 g/g (700 mg/g), as measured from a 24 hour urine collection by a central laboratory at Screening
• Stable on a maximally tolerated dose of ACEi and/or ARB for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of SGLT2i, MRA, and/or GLP-1A if stable for at least 12 weeks prior to Screening. Participants are expected to stay on a stable dose of ACEi, ARB, SGLT2i, MRA and/or GLP-1A for the duration of the study.

You may not qualify if:

• Chronic Kidney Disease (CKD), either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN
• Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasia
• Diagnosis of active IgA vasculitis
• Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (2025)
• Current clinical diagnosis of nephrotic syndrome
• Known history of heart failure or conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites
• Current severe infection requiring antimicrobials, or history of recurrent, severe infections as determined by the Investigator

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

Interventions

Atrasentan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 17, 2028
• Study Completion (Estimated): December 25, 2030
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share