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Monoclonal Antibodies

BION-1301 for IgA Nephropathy

Phase 3
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
Male and female subjects aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
Screening weight of at least 50 kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks or approximately 2 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing BION-1301, a new medication, in adults with IgA nephropathy. The goal is to see if it can help reduce the amount of protein leaking into their urine by improving kidney function.

Who is the study for?
Adults over 18 with IgA Nephropathy, weighing at least 50 kg, can join this trial. They must agree to use contraception and follow the study's procedures. People using immunosuppressants, with severe allergies to monoclonal antibodies, diabetic complications, or a history of Type 1 Diabetes cannot participate.
What is being tested?
The trial is testing BION-1301 for safety and effectiveness in treating IgA Nephropathy compared to a placebo (a substance with no active drug). Participants will be randomly assigned to receive either BION-1301 or the placebo.
What are the potential side effects?
Possible side effects of BION-1301 may include allergic reactions due to its nature as a monoclonal antibody. Specific side effects are not listed but typically could involve immune system responses or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older and have signed the consent form.
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I weigh at least 50 kg.
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I agree to use birth control as directed and follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks or approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks or 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
Change in proteinuria
Secondary study objectives
Change in eGFR

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BION-1301Experimental Treatment1 Intervention
600mg subcutaneous administration every 2 weeks for 104 weeks
Group II: PlaceboPlacebo Group1 Intervention
subcutaneous administration every 2 weeks for 104 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BION-1301
2022
Completed Phase 1
~40

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Immunoglobulin A Nephropathy (IgAN) include angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), corticosteroids, and immunosuppressive agents. These treatments primarily aim to reduce proteinuria and control blood pressure, thereby slowing disease progression. The inhibition of APRIL (A Proliferation-Inducing Ligand), as studied in the BION-1301 trial, targets a specific pathway involved in the production of IgA antibodies. By inhibiting APRIL, the treatment aims to reduce the levels of pathogenic IgA, which is crucial in preventing the formation of immune complexes that damage the kidneys. This targeted approach is significant for IgAN patients as it addresses the underlying cause of the disease, potentially offering a more effective and specific treatment option compared to broader immunosuppressive therapies.

Find a Location

Who is running the clinical trial?

Chinook Therapeutics, Inc.Lead Sponsor
8 Previous Clinical Trials
740 Total Patients Enrolled
2 Trials studying Immunoglobulin A Nephropathy
456 Patients Enrolled for Immunoglobulin A Nephropathy

Media Library

BION-1301 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05852938 — Phase 3
Immunoglobulin A Nephropathy Research Study Groups: Placebo, BION-1301
Immunoglobulin A Nephropathy Clinical Trial 2023: BION-1301 Highlights & Side Effects. Trial Name: NCT05852938 — Phase 3
BION-1301 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05852938 — Phase 3
Immunoglobulin A Nephropathy Patient Testimony for trial: Trial Name: NCT05852938 — Phase 3
~131 spots leftby Dec 2025