A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
ConditionImmunoglobulin A Nephropathy (IgAN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- zigakibart
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov