The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52
Time frame: Baseline to Week 52
Change from baseline in GdIgA1 at Week 52
Time frame: Baseline to Week 52
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time frame: Baseline to Week 52
Time to Gd-IgA1 reduction greater than or equal to 50% during double-blind (DB) treatment phase
Time frame: Up to 52 weeks
Time to UPCR reduction greater than or equal to 30% during double-blind (DB) treatment phase
Time frame: Up to 52 weeks
Hematuria resolution at Week 52 (among participants with hematuria at baseline)
Time frame: Baseline to Week 52
Proportion of study participants reaching a Urinary Protein Excretion (UPE) below 0.5 g/d at Week 52
Time frame: Baseline to Week 52
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed during the DB Treatment Phase (up to 52 weeks)
Time frame: Up to 52 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed during the DB Treatment Phase (up to 52 weeks)
Time frame: Up to 52 Weeks
Change from baseline difference in the magnitude of the treatment effect (BHV-1400 versus placebo) in eGFR at Week 52.
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Assessed by the lower limit of the 1-sided 80% confidence interval change from baseline difference
Time frame: Baseline to Week 52
Number of participants experiencing any of the following during the DB phase: at least 30% reduction relative to baseline in eGFR for at least 30 days, eGFR <15 mL/min/1.73m2 for at least 30 days, chronic dialysis ≥30 days, kidney transplant, death
Time frame: Up to 52 Weeks
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed through the Open-label Treatment Phase
Time frame: Up to 104 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed through the Open-label Treatment Phase
Time frame: Up to 104 Weeks