Currently Enrolling
Interventional

OMS721 for Patients with IgAN

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

This Phase 3 study will determine is OMS721 is safe and effective at reducing symptoms for patients with IgAN.

Currently Enrolling
Interventional

OMS721 for Patients with IgAN

Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy

This Phase 3 study will determine is OMS721 is safe and effective at reducing symptoms for patients with IgAN.

Eligibility Criteria
Patient Population

IgA Nephropathy

Age

18 — 26+

History of transplant allowed?

No

History of dialysis allowed?

No

eGFR

30 — > 60

UPCR

1.0 or Less — 3.0 or Above

Permitted medication history

Ace Inhibitors/ARB, Prednisone (Steroids), Abatacept, Acthar, Cellcept (AKA Mycophenolate), Cytoxan (Cyclophosphamide), Prograf (AKA Tacrolimus), Rituximab (AKA Rituxan), Other, None

Patient should be

Treatment Resistant, Steroid Dependent, Neither of These

About the Drug
What is involved for the patient

Patients will be involved with the trial for about 2 years, and will take either the study medication or the placebo.

Sponsor

Omeros Corporation

Target Enrollment

430

Estimated End Date

April 2023

About the Trial
Study Drug

OMS721

Study Goal

To determine if OMS721 reduces proteinuria in patients with IgAN.

About the drug or intervention

MASP-2, is a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system.

Boston, MA
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