A Study of Zigakibart in Adults With IgA Nephropathy
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Sponsor: Novartis Pharmaceuticals
Open for Predictions · 2 endpoints
Key Facts
Primary Endpoints (CT.gov)
Change from baseline in eGFR
Time frame: Baseline and 104 weeks or approximately 2 years
Secondary Endpoints
Change in proteinuria (natural log UPCR)
Annualized rate of change in eGFR
Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)
Eligibility Criteria
Inclusion Criteria: * Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor. * eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation. * Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory. * Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi…
Read full criteria on CT.gov →✦ Analyst Commentary
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