NCT07146906 · Novartis Pharmaceuticals
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
(SHIFT)
What this study is about
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
View original scientific description
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Denver, Colorado
- Acworth, Georgia
- Iowa City, Iowa
- Edina, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations