Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
BEYOND
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Brief Description
The purpose of this study is to evaluate the safety and efficacy of BION-1301 in adults with IgA nephropathy.
Trial Physician / Study Coordinator
Jasmine Minasian
Email PhoneSite Name
Kidney Disease Medical Group
1505 Wilson terrace, Suite 155 Glendale, CA 91206 USA
Sponsor
Chinook Therapeutics
Study Drug
Zigakibart
Estimated enrollment
292
Estimated end date
May 1, 2028
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
BEYOND
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Brief Description
The purpose of this study is to evaluate the safety and efficacy of BION-1301 in adults with IgA nephropathy.
Trial is for people with
Primary immunoglobulin A nephropathy (IgAN) at risk of progressive loss of kidney function.
Study Goal
The goal of the BEYOND study is to evaluate the safety and efficacy of zigakibart in reducing proteinuria and slowing down kidney disease progression.
What is involved for the Patient?
Patients will have assessments of safety and efficacy every 2 weeks over 2 years. Patients will also be followed up for safety for an additional 24 weeks after the last dose. Virtual trial options may include telemedicine, home health nurse visits and the option to self-administer at home (subject to local regulations and sponsor approval). Patients may be reimbursed for trial-related expenses.
About the drug or intervention
Zigakibart (BION-1301) is a novel, humanized monoclonal antibody that binds and blocks APRIL (A PRoliferation-Inducing Ligand).