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)
The purpose of this study is to evaluate the safety and efficacy of BION-1301 in adults with IgA nephropathy.
Trial Physician / Study Coordinator
Danielle Serafim
Email PhoneSite Name
Nephrology Associates, P.C.
56-16 174th St, 2nd Floor, Room 200, Fresh Meadows New York City, New York 11365 USA
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)
The purpose of this study is to evaluate the safety and efficacy of BION-1301 in adults with IgA nephropathy.
Eligibility Criteria
Patient Population
Primary immunoglobulin A nephropathy (IgAN) at risk of progressive loss of kidney function.
Age
18 — 26+
History of transplant allowed?
No
History of dialysis allowed?
No
eGFR
15 — > 60
UPCR
1.0 or Less — 3.0 or Above
Permitted medication history
Ace Inhibitors/ARB, Other
Patient should be
Neither of These
About the Drug
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.
Sponsor
Chinook Therapeutics
Estimated End Date
May 1, 2028
About the Trial
Study Drug
Zigakibart
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.
About the drug or intervention
Zigakibart (BION-1301) is a novel, humanized monoclonal antibody that binds and blocks APRIL (A PRoliferation-Inducing Ligand).