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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment until end of treatment, up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until end of treatment, up to approximately 2 years
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
3 Trials studying Immunoglobulin A Nephropathy
748 Patients Enrolled for Immunoglobulin A Nephropathy
Cailin Sibley, MDStudy DirectorChinook Therapeutics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently breastfeeding as a woman.You have had a severe allergic reaction to any type of monoclonal antibody or any component of BION-1301.
Research Study Groups:
This trial has the following groups:- Group 1: BION-1301 Q2W
- Group 2: BION-1301 Q4W
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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