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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

Study Summary

This trial is testing a drug to treat adults with a kidney disease called IgA nephropathy.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Assess the immunogenicity of BION-1301

Assess the pharmacokinetics of BION-1301

Characterize the pharmacodynamic effect of BION-1301

Other outcome measures

Evaluate the preliminary clinical activity of BION-1301 in patients with IgAN

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Chinook Therapeutics, Inc.Lead Sponsor

7 Previous Clinical Trials

608 Total Patients Enrolled

2 Trials studying Immunoglobulin A Nephropathy

344 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings to participate in this investigation?

"Affirmative. Based on the information hosted by clinicaltrials.gov, this medical trial is actively seeking participants to join the study which was first posted in September 10th 2020 and subsequently updated December 22nd 2020. The team managing the project seeks 20 volunteers from a single site."

Answered by AI

What is the aggregate enrollment of participants in this research study?

"Affirmative. According to the records on clinicaltrials.gov, this research is open for recruitment and was first listed on September 10th 2020 with a recent update occurring December 22nd 2020. The study seeks 20 participants from 1 medical site."

Answered by AI

Has the Food and Drug Administration accepted BION-1301 as a legitimate medication?

"As the trial is in Phase 2, data points on the safety of BION-1301 are available and it earned a rating of 2. However, efficacy still needs to be established through further research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-Label Extension Study of BION-1301 in IgA Nephropathy

2020. "Open-Label Extension Study of BION-1301 in IgA Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684745.

All > Iga Nephropathy