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Currently Enrolling
Interventional

ORIGIN

ORIGIN IgAN Study

Brief Description

The purpose of the study it to measure the effectiveness of the study medication at improving kidney function to prevent damage in people who have IgAN.

Trial Physician / Study Coordinator

Rik Alliet

Email Phone
Site Name

AZ Delta
AZ Delta Deltalaan 1, Roeselare, Belgium, 8800

Sponsor

Vera Therapeutics

Study Drug

atacicept

Estimated enrollment

105 participants

Estimated end date

The estimated end date of enrollment of the study is in the second quarter of 2022

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

ORIGIN

ORIGIN IgAN Study

Brief Description

The purpose of the study it to measure the effectiveness of the study medication at improving kidney function to prevent damage in people who have IgAN.

Trial is for people with

A diagnosis of IgAN confirmed by a kidney biopsy with the past 10 years who are on a stable, prescribed regimen of an RAASi (for example, ACE/ARB) medication for at least 12 weeks.

What is involved for the Patient?

Complete assessment like physical exams, blood tests and 24 hour urine. Patients will be assigned to receive active study medication or placebo. There is a 70% chance of being assigned to receive active study mediation. Receive once-weekly injections (at the clinic or at home). Attend clinic visits over the course of 9 months. After completing the 9 months all participants will be able to receive active study medication for an additional 60 weeks.

About the drug or intervention

Atacicept is designed to help prevent the buildup of IgA in the kidneys by controlling the immune response that causes IgAN.

Roeselare, Belgium
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.

Clinical studies are any studies that involve people. There are two main types: observational and interventional. In an observational trial, researchers track health outcomes over time in groups of participants to look for patterns that help us better understand a disease. In an interventional trial, participants receive specific interventions, which can include new treatments or behavorial changes (e.g., diet changes). To learn more about clinical research, please visit the NephCure website.