Recruiting

Phase 2

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

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07146906

Conditions

Immunoglobulin A Nephropathy (IgAN)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

zigakibart

Study Details

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)

Study ID

NCT07146906

Start date

Mar 26, 2026

Status verified date

Aug, 2026

Completion date

Oct 18, 2030

Anticipated

Primary completion date

Jul 12, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: zigakibart

zigakibart injections every second week for two years

Interventions

zigakibart

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

Primary outcome measure

Change in mesangial IgA deposition [ Time Frame: Baseline to Week 53 or 105 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111 novartis.email@novartis.com

Locations

Colorado Kidney Care Nephrology

Recruiting

Denver, Colorado, United States, 80230

Contacts

Leigh Collins

lcollins@cokidneycare.com

Principal Investigator:

Laura Kooienga

American Clinical Trials

Recruiting

Acworth, Georgia, United States, 30101

Contacts

Chidi Asuzu

chidi.asuzu@cowryhealth.com

Principal Investigator:

Chinedu Nweke

Univ Of Iowa Hospitals And Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Christine Zabawa

+1 319 356 1826 christine-zabawa-hamilton@uiowa.edu

Principal Investigator:

Lama Noureddine

Inter Med Consultants

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Charlene Newton

charlene.newton@davita.com

Principal Investigator:

Jonathan Tolins

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-10.