Currently Enrolling
Interventional

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

Shirin Hasan

Email Phone 847-570-2512
Site Name

NorthShore University HealthSystem
2650 Ridge Avenue Evanston, Illinois 60201 USA

Sponsor

Chinook Therapeutics

Study Drug

Zigakibart

Estimated enrollment

292

Estimated end date

May 1, 2028

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Currently Enrolling
Interventional

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).

Evanston, IL
Frequently Asked Questions

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

See other frequently asked questions