A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Novartis Pharmaceuticals · NCT07146906
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 32
- US sites recruiting
- 5
- Study start
- March 26, 2026
- Record last updated
- October 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Being studied: zigakibart
Conditions: Immunoglobulin A Nephropathy (IgAN)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
UC San Francisco Medical Center
San Francisco, CA 94143-0348
Site contact: Juan Espinoza · +1 415 476 8338 · juan.espinoza@ucsf.edu
Colorado Kidney Care Nephrology
Denver, CO 80230
Site contact: Georgi Krastev · gkrastev@cokidneycare.com
American Clinical Trials
Acworth, GA 30101
Site contact: Chidi Asuzu · chidi.asuzu@cowryhealth.com
Univ Of Iowa Hospitals And Clinics
Iowa City, IA 52242
Site contact: Christine Zabawa · +1 319 356 1826 · christine-zabawa-hamilton@uiowa.edu
Inter Med Consultants
Edina, MN 55435
Site contact: Charlene Newton · charlene.newton@davita.com
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111 · novartis.email@novartis.com