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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

Study Summary

This trial tests if a drug is safe and effective in treating IgA Nephropathy in adults.

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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in proteinuria
Secondary outcome measures
Change in eGFR

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

Find a Location

Who is running the clinical trial?

Chinook Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
336 Total Patients Enrolled
1 Trials studying Immunoglobulin A Nephropathy
52 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

Frequently Asked Questions

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

What is the extent of availability for this research endeavor?

"This study is actively being conducted at the Carabello Kidney - Victor Carabello, MD in Los Angeles, Colorado; Valiance Clinical Research in S. Gate, Illinois; University of Colorado Anschutz Medical Campus in Aurora, Indiana and 9 additional locations across the US."

Answered by AI

To what extent can BION-1301 be considered a risk to human health?

"The risk evaluation of BION-1301 is 3 out of a possible score of 3 given the existing evidence on its efficacy and safety collected from previous clinical trials."

Answered by AI

How many individuals are involved in this investigative endeavor?

"Affirmative, the information on clinicaltrials.gov verifies that this medical trial is presently seeking participants. This experiment was first posted in June of 2023 and has been updated as recently as July 12th 2023; 292 patients are required from 9 distinct sites for its completion."

Answered by AI

Is this research accepting new participants?

"Affirmative, according to clinicaltrials.gov the study is actively searching for participants. This medical trial was posted on June 27th 2023 and subsequently updated on July 12th 2023; 292 individuals need to be recruited from 9 distinct sites."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
California
What site did they apply to?
Valiance Clinical Research
Other
Kidney Disease Medical Group
Knoxville Kidney Center, PLLC.
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried other things but didn't help. Just outta prison doing 30 years..and I need to start taking care of myself...I only have one kidney at 70 percent.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. NANI Research, LLC: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of BION-1301 in Adults With IgA Nephropathy
2023. "A Study of BION-1301 in Adults With IgA Nephropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05852938.
All > Iga Nephropathy
~191 spots leftby Dec 2025
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