Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05852938
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-05-02
Brief Title:
A Study of BION-1301 in Adults With IgA Nephropathy
Sponsor:
Chinook Therapeutics Inc
Organization:
Chinook Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy The BEYOND Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Detailed Description:
Approximately 272 participants with eGFR 30 mLmin173m2 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 participants 10 participants per arm with biopsy-confirmed IgAN and eGFR of 20 to 30 mLmin173 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
Participants will have assessments of safety and efficacy for 25 years up to 134 weeks 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
The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy
Participants will have assessments of safety and efficacy for 25 years up to 134 weeks 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None