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Currently Enrolling
Interventional

EPPIK (FSGS & MCD)

The EPPIK Clinical Study for Children with FSGS and MCD

Brief Description

The EPPIK study will evaluate the investigational drug, sparsentan, for the treatment of selected rare kidney diseases. The investigational approach is to lower proteinuria levels with sparsentan and slow the loss of kidney function in children ages 1-17 with:

• Focal segmental glomerulosclerosis (FSGS)
• Minimal change disease (MCD)

See also the EPPIK Clinical Study for Children with IgAN, IgAV, and Alport Syndrome.

Trial Physician / Study Coordinator

Arielle Swenson

Email Phone
Site Name

Children's Hospital of Philadelphia
3401 Civic center Blvd, Philadelphia, PA, 19104

Estimated enrollment

The entire EPPIK study (including FSGS, MCD, IgAN, IgAV and Alport Syndrome) will enroll approximately 57 children.

Estimated end date

To be determined

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

EPPIK (FSGS & MCD)

The EPPIK Clinical Study for Children with FSGS and MCD

Brief Description

The EPPIK study will evaluate the investigational drug, sparsentan, for the treatment of selected rare kidney diseases. The investigational approach is to lower proteinuria levels with sparsentan and slow the loss of kidney function in children ages 1-17 with:

• Focal segmental glomerulosclerosis (FSGS)
• Minimal change disease (MCD)

See also the EPPIK Clinical Study for Children with IgAN, IgAV, and Alport Syndrome.

Trial is for people with

For children ages 1-17 with:

• Focal segmental glomerulosclerosis (FSGS)
• Minimal change disease (MCD)

Study Goal

The goals of the study are to evaluate the safety and effectiveness of sparsentan on children with FSGS, MCD, IgAN, IgAV and Alport syndrome.

What is involved for the Patient?

Patients will participate for about 2 years and 3 months and will receive sparsentan.

About the drug or intervention

Participants receive sparsentan, the investigational drug, taken as a liquid by mouth.

Philadelphia, PA
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.