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Currently Enrolling
Interventional

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

Christian Turull-Arocho

Email Phone
Site Name

New York Nephrology
62 Hackett Boulevard Albany, NY 12209

Currently Enrolling
Interventional

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).

Albany, NY
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