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Monoclonal Antibodies

BION-1301 for Immunoglobulin A Nephropathy

Phase 2
Recruiting
Research Sponsored by Chinook Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until end of treatment, up to approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing BION-1301, a medicine that blocks a harmful protein, in adults with IgA nephropathy from a previous study. The medicine helps prevent kidney damage by stopping a specific protein from working.

Eligible Conditions
  • Immunoglobulin A Nephropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until end of treatment, up to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until end of treatment, up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes from baseline in safety laboratory parameters
Number of subjects with serious adverse events (SAEs) as assessed by NCI-CTCAE
Number of subjects with treatment-emergent adverse events (TEAEs) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Secondary study objectives
Assess the immunogenicity of BION-1301
Assess the pharmacokinetics of BION-1301
Characterize the pharmacodynamic effect of BION-1301
Other study objectives
Evaluate the preliminary clinical activity of BION-1301 in patients with IgAN

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: BION-1301 Q4WExperimental Treatment1 Intervention
BION-1301 will be administered once every 4 weeks (Q4W) as an intravenous infusion.
Group II: BION-1301 Q2WExperimental Treatment1 Intervention
BION-1301 will be administered once every 2 weeks (Q2W) as an intravenous infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BION-1301
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Chinook Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
1,012 Total Patients Enrolled
2 Trials studying Immunoglobulin A Nephropathy
456 Patients Enrolled for Immunoglobulin A Nephropathy
Cailin Sibley, MDStudy DirectorChinook Therapeutics

Media Library

BION-1301 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04684745 — Phase 2
Immunoglobulin A Nephropathy Research Study Groups: BION-1301 Q2W, BION-1301 Q4W
Immunoglobulin A Nephropathy Clinical Trial 2023: BION-1301 Highlights & Side Effects. Trial Name: NCT04684745 — Phase 2
BION-1301 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684745 — Phase 2
~4 spots leftby Nov 2025
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