Currently Enrolling
Interventional

The PROTECT Trial for IgAN Patients

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Brief Description

This study will be a randomized, active-control study that will help to determine if Sparsentan is effective at improving symptoms of IgAN.

Study Coordinator

Yeong Hoon Kim

Email Phone(+82) 51 890 6986
Site Name

Inje University Pusan Paik Hospital
P-203 Imjae Building 75 Bokji-ro, Busanjin-gu Busan, 47392 Korea

Sponsor

Retrophin, Inc.

Study Drug

Sparsentan

Estimated enrollment

280

Estimated end date

April 2023

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.
Find other locations for this trial:
Currently Enrolling
Interventional

The PROTECT Trial for IgAN Patients

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy

Brief Description

This study will be a randomized, active-control study that will help to determine if Sparsentan is effective at improving symptoms of IgAN.

Trial for people with

IgA Nephropathy (IgAN)

Study Goal

To evaluate the potential benefit of Sparsentan on kidney function by analyzing change in proteinuria (protein in urine) and estimated glomerular filtration rate (eGFR) as compared to current standard treatment.

What is involved for the Patient?

Patients will take a daily dose of the study medication, and will be involved with the trial for about 2 years.

About the drug or intervention

Sparsentan is a tablet taken orally.

Find other locations for this trial:
Busan, South Korea
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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