Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m\^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301, Novartis FUB523, or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to \< 30 mL/min/1.73 m\^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on eGFR as measured by the change from Baseline in eGFR. Following completion of the 104-week treatment period, subjects may be eligible to enroll in an open-label extension (OLE) study to receive open-label treatment with BION-1301 under a separate protocol. Subjects who do not enroll in the OLE will enter the protocol-specified 24-week safety follow-up period. To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
383
Change from baseline in eGFR
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
Time frame: Baseline and 104 weeks or approximately 2 years
Change in proteinuria (natural log UPCR)
Change in urine protein: creatinine ratio (UPCR) from baseline to week 40
Time frame: Baseline and 40 weeks or approximately 9 months
Annualized rate of change in eGFR
Annualized eGFR slope estimated over 104 weeks using the CKD-EPI 2021 creatinine equation
Time frame: 104 weeks or approximately 2 years
Effect of BION-1301 on specific clinical composite endpoints (30% eGFR reduction)
Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study: * At least 30% reduction in eGFR sustained for at least 30 days * eGFR \< 15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis, ≥ 30 days * Kidney transplantation * All-cause mortality
Time frame: Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Effect of BION-1301 on specific clinical composite endpoints (40% eGFR reduction)
Percent of participants meeting the composite endpoint of experiencing at least 1 of the following during the study: * At least 40% reduction in eGFR sustained for at least 30 days * eGFR \< 15 mL/min/1.73m\^2, sustained for at least 30 days * Chronic dialysis, ≥ 30 days * Kidney transplantation * All-cause mortality
Time frame: Baseline and Weeks 4, 12, 24, 40, 52, 64, 76, 88, and 104
Percent Change in Proteinuria and Total Urine Protein
Percent of participants achieving reduction of proteinuria to \< 1.0 g/day at Week 40 and a ≥ 25% decrease in total urine protein from Baseline
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University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States
Nephrology Consultants, LLC
Huntsville, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
Valiance Clinical Research
South Gate, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Denver Nephrology Research Division
Denver, Colorado, United States
Vida Medical Centers - Pembroke Pines
Pembroke Pines, Florida, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Nephrology Associales of Northern Illinois and Indiana
Hinsdale, Illinois, United States
Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
Fort Wayne, Indiana, United States
...and 190 more locations
Time frame: 40 weeks or approximately 9 months