A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of BION-1301 in Adults with IgA Nephropathy

Primary Objective

To test a new medication (BION-1301) for the treatment of IgAN.

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Description

The medication is taken by injection every 2 weeks for two years.

Details
Age
Adult
Eligibility
Biopsy-proven IgAN within past 10 years; stable on ACEi/ARB for at least 12 weeks.1. 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 Medical Monitor. 3. eGFR ≥ 30 mL/min/1.73m2 at Screening based on the 2021 CKD-EPI equation (Inker, 2021a) (for the exploratory cohort only: eGFR of ≥ 20 to < 30 mL/min/1.73 m2). 4. Total urine protein ≥ 1.0 g/day and UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory. 5. Stable on a maximally tolerated dose of ACEi/ARB for at least 12 weeks prior to Screening unless intolerant to ACEi/ARB. May also be on a stable and well tolerated dose of SGLT2i and/or ERAs/MRAs for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on the ACEi/ARB, SGLT2i and/or the ERAs/MRAs for the duration of the study. 6. Body mass index (BMI) between 18 and 40 kg/m2. 7. Screening weight of 45 to 150 kg.
Locations

Renal Research Center

Principal Investigator
Photograph of James Dylewski

James Dylewski

Study ID

Protocol Number: 23-0695

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