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Interventional
Asheville, NC
The NefIgArd Study

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Brief Description

This clinical trial will evaluate the efficacy of Nefecon compared to matching placebo in patients with primary IgAN on a background of optimized RAS inhibitor therapy.

Trial for people with

Primary IgA Nepropathy

Study Goal

To determine if Nefecon reduces proteinuria in patients with IgAN, and as a result in long term delaying the disease progression.

What is involved for the Patient?

Eligible participants will be randomly assigned to receive either 16 mg Nefecon or placebo. During Part A, participants will be asked to take their medication in the form of capsules to be swallowed by mouth once daily for 9 months. All participants included in the study will continue into Part B, which is an observational long-term follow up. During this time participants’ renal function will be followed. No investigational drug will be given during this period.

About the drug or intervention

Nefecon is a new oral formulation of budesonide that is designed to specifically deliver the drug to a place in the intestine where most of the immune cells producing IgA are located.

  • Study CoordinatorLaurie Lowdermilk (Marino)
  • Study Coordinator Emaillmarino@mtnkidney.com
  • Study Coordinator Phone828.258.8545
  • Site NameMountain Kidney & Hypertension Associates, P.A.
  • Address10 McDowell St, Asheville, NC, 28801
  • SponsorCalliditas Therapeutics AB
  • Study DrugNefecon
  • Estimated enrollment450
  • Estimated end dateDecember 2024
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.
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.

 

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