NCT07146906 A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
| NCT ID | NCT07146906 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Immunoglobulin A Nephropathy (IgAN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2030-07-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2026-03-26 with a primary completion date of 2030-07-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Eligibility 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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07146906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immunoglobulin A Nephropathy (IgAN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07146906 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07146906 currently recruiting?
Yes, NCT07146906 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07146906 trial being conducted?
This trial is being conducted at San Francisco, United States, Denver, United States, Acworth, United States, Iowa City, United States and 11 additional locations.
Who is sponsoring the NCT07146906 clinical trial?
NCT07146906 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 32 participants.