A Study of BION-1301 in Adults With IgA Nephropathy
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|ClinicalTrials.gov Identifier: NCT05852938|
Recruitment Status : Recruiting
First Posted : May 10, 2023
Last Update Posted : July 14, 2023
|Condition or disease||Intervention/treatment||Phase|
|IgA Nephropathy Immunoglobulin A Nephropathy||Drug: BION-1301 Drug: Placebo||Phase 3|
Approximately 272 patients with eGFR ≥ 30 mL/min/1.73m2 and with biopsy-proven IgAN will be randomized to receive 600mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 subjects (10 subjects per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to < 30 mL/min/1.73 m2.
The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy.
Subjects will have assessments of safety and efficacy for 2.5 years (up to 134 weeks). To facilitate study participation over this time period, where allowed by local regulations, options for remote study visits using telemedicine and home health may be offered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||292 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)|
|Actual Study Start Date :||June 27, 2023|
|Estimated Primary Completion Date :||December 22, 2025|
|Estimated Study Completion Date :||May 1, 2028|
600mg subcutaneous administration every 2 weeks for 104 weeks
BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.
Other Name: Zigakibart
Placebo Comparator: Placebo
subcutaneous administration every 2 weeks for 104 weeks
Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.
- Change in proteinuria [ Time Frame: 40 weeks or approximately 9 months ]The change in urine protein: creatinine ratio (UPCR) from baseline to Week 40.
- Change in eGFR [ Time Frame: 104 weeks or approximately 2 years ]The change in eGFR from baseline to Week 104.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05852938
|Contact: Chinook Therapeutics||(206) 485 - email@example.com|
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