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Monoclonal Antibodies
BION-1301 for IgA Nephropathy
Phase 1 & 2
Waitlist Available
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 or female ≥18 years old at Screening
Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants followed from date of enrollment until the end of study, assessed up to 76 weeks.
Awards & highlights
Study Summary
This trial will study the effects of BION-1301 in healthy volunteers and adults with IgA Nephropathy. The safety, tolerability, and how the body processes and responds to the drug will be evaluated.
Who is the study for?
Adults with IgA Nephropathy (IgAN) who have had a kidney biopsy in the last 10 years, protein in urine, and stable kidney function. They must be non-smokers, not pregnant or breastfeeding, not using drugs or alcohol excessively, and agree to use contraception. Healthy volunteers aged 18-55 with a BMI of 18-35 kg/m^2 can also participate.Check my eligibility
What is being tested?
The trial is testing BION-1301's safety and effects on the body compared to a placebo. It involves giving either one dose or multiple doses of BION-1301/placebo to see how it's tolerated by healthy people and those with IgAN.See study design
What are the potential side effects?
Possible side effects are not detailed but may include allergic reactions due to hypersensitivity to components of BION-1301 or similar monoclonal antibodies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My BMI is between 18 and 35, and I weigh at least 50 kg.
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My kidney function is at a safe level for the trial.
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My BMI is between 18 and 40, and I weigh at least 50 kg.
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I am between 18 and 55 years old and in good health.
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I cannot become pregnant.
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I agree to follow the study's rules for using birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ participants followed from date of enrollment until the end of study, assessed up to 76 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants followed from date of enrollment until the end of study, assessed up to 76 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Severity of TEAEs as assessed according to NCI-CTCAE
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 4 Retreatment: BION-1301Experimental Treatment1 Intervention
Eligible participants from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly.
Group II: Part 3: BION-1301Experimental Treatment1 Intervention
Two cohorts of participants will receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly.
Group III: Part 2: BION-1301Experimental Treatment1 Intervention
Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion.
Group IV: Part 1: BION-1301Experimental Treatment1 Intervention
Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion.
Group V: Part 1: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo administered by IV infusion.
Group VI: Part 2: PlaceboPlacebo Group1 Intervention
Participants will receive placebo by IV infusion.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Chinook Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
525 Total Patients Enrolled
2 Trials studying Immunoglobulin A Nephropathy
344 Patients Enrolled for Immunoglobulin A Nephropathy
Shuping Yang, M.D.Study DirectorChinook Therapeutics, Inc.
Chun LamStudy DirectorChinook Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not smoked or used nicotine products for at least 3 months.I do not have any major health issues that could make this study unsafe for me.I agree to follow the study's rules for birth control for 6 months after the last dose.I am 18 years old or older.My IgA nephropathy was confirmed by a biopsy in the last 10 years.You have regularly consumed alcohol, used marijuana in the last 3 months, or used hard drugs like cocaine and phencyclidine in the last year. If a blood or urine test shows that you have used drugs or alcohol, you may be excluded from the study.I am not pregnant or breastfeeding.My BMI is between 18 and 35, and I weigh at least 50 kg.You have a high level of protein in your urine.I have been on a stable dose of ACE inhibitors or ARBs for 3 months, or I cannot tolerate them.My urine protein levels are high and have increased since my last treatment.My kidney function is at a safe level for the trial.My BMI is between 18 and 40, and I weigh at least 50 kg.I haven't donated blood, plasma, or platelets recently before starting the study drug.I am not allergic to BION-1301 or similar medications.My IgA nephropathy is not caused by other conditions like Henoch-Schönlein purpura or alcohol-related liver disease.I am between 18 and 55 years old and in good health.I cannot become pregnant.The doctor thinks that it's not a good idea for you to continue taking BION-1301 because it might not help you or could be risky for you.I agree to follow the study's rules for using birth control.I haven't taken high-dose steroids or immunosuppressants in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part 4 Retreatment: BION-1301
- Group 2: Part 1: BION-1301
- Group 3: Part 1: Placebo
- Group 4: Part 2: BION-1301
- Group 5: Part 2: Placebo
- Group 6: Part 3: BION-1301
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you tell me how many facilities are participating in this research project?
"There are 11 sites currently running this study, which include locations such as Desert Cities Dialysis - Amethyst in Victorville, Liberty Research Center in Arlington, and Genesis Clinical Research in Tampa."
Answered by AI
How many participants are accepted into this trial?
"That is correct. As indicated by the information on clinicaltrials.gov, this trial is still in the process of recruiting patients. The trial was first posted on April 8th, 2019 and was last updated on June 6th, 2022. In total, the trial needs 112 participants from 11 different sites."
Answered by AI
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