Last updated 4 days ago
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
32 patients around the world
Available in United States, Brazil
This is an open-label multicenter study where participants are randomized into one of two
groups, where the only difference between the groups is the on-treatment biopsy time
point, end of the first year of treatment (Group A) or at the end of the second year of
treatment (Group B).
The total study duration for each participant may be up to 125 weeks, including the
maximum screening period (8 weeks), the treatment period (104 weeks), and the safety
follow up period (13 weeks).
Novartis Pharmaceuticals
32Patients around the world
This study is for people with
Nephropathy
Iga nephropathy
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- 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.
- 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.
StudySHIFT
SponsorNovartis Pharmaceuticals
Study typeInterventional
Conditions
Iga nephropathy
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07146906
