A Study of BION-1301 in Adults With IgA Nephropathy
A study of BION-1301 in adults with IgA nephropathy
ClinicalTrials.gov ID: NCT05852938
Sponsor: Chinook Therapeutics, Inc.
Information provided by: Chinook Therapeutics, Inc. (Responsible Party)
Last Update Posted: 2024-05-20
Brief Summary:
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Detailed Description:
Approximately 272 patients with eGFR ≥ 30 mL/min/1.73m2 and with biopsy-proven IgAN will be randomized to receive 600 mg 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 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 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.
Official Title:
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Intervention / Treatment:
- Drug: BION-1301
- Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-07-27
|
| Primary Completion (Estimated) |
2026-01-19
|
| Study Completion (Estimated) |
2028-05-08
|
| Enrollment (Estimated) | 292 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CHK02-02
|