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

NCT07146906 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: CFUB523A122012024-519699-24U1111-1323-5075
• Study Type: interventional
• Target: 32
• Locations: 5 countries
• Sites: 8

Brief Summary

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

Conditions

Immunoglobulin A Nephropathy (IgAN)

Keywords

zigakibart; FUB523; anit-APRIL; SHIFT; IgA nephropathy; IgAN; proteinuria; kidney; biopsy; adults

Outcome Measures

Primary Outcomes (1)

• Change in mesangial IgA deposition

  Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining

  Baseline to Week 53 or 105

Secondary Outcomes (11)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Day 1 to Week 118

• Change in MEST-C score

  Baseline to Week 53 or 105

• Change in CD68+ cells in glomeruli and tubulo-interstitial compartment

  Baseline to Week 53 or 105

• Change in complement component C3c

  Baseline to Week 53 or 105

• Change in UPCR

  Baseline to Week 53 and 105

Study Arms (1)

zigakibart

EXPERIMENTAL

zigakibart injections every second week for two years

Biological: zigakibart

Interventions

zigakibart BIOLOGICAL

zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

zigakibart

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Untreated hypertension or uncontrolled hypertension despite treatment (i.e., resistant hypertension)
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (8)

Colorado Kidney Care Nephrology

Denver, Colorado, 80230, United States

RECRUITING

American Clinical Trials

Acworth, Georgia, 30101, United States

RECRUITING

Inter Med Consultants

Edina, Minnesota, 55435, United States

RECRUITING

Novartis Investigative Site

Shanghai, 200025, China

RECRUITING

Novartis Investigative Site

Kawasaki, Kanagawa, 213-8587, Japan

RECRUITING

Novartis Investigative Site

Miyazaki, 889-1692, Japan

RECRUITING

Novartis Investigative Site

Seoul, Korea, 03080, South Korea

RECRUITING

Novartis Investigative Site

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

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

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; novartis.email@novartis.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a ratio of 1:1 to undergo the on-treatment biopsy at one of two possible timepoints

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: March 26, 2026
• Primary Completion (Estimated): July 12, 2030
• Study Completion (Estimated): October 18, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1); US (3); JP (2); CN (1); KR (1)