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Enrollment Closed
Interventional

The PODOCYTE Study

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS  (PODOCYTE)

Brief Description

This study will examine the effectiveness of Acthar® Gel in adults subjects with FSGS who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

Study Coordinator

Clinical Trial Team

Email Phone 800-556-3314
Site Name

University of Alambama at Birmingham
1720 2nd Ave. S, ZRB 635

Sponsor

Mallinckrodt Pharmaceuticals

Study Drug

Acthar

Estimated enrollment

236

Estimated end date

June, 2021

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:
Enrollment Closed
Interventional

The PODOCYTE Study

Treatment of Proteinuria Due to Treatment Resistant or Treatment Intolerant Idiopathic FSGS  (PODOCYTE)

Brief Description

This study will examine the effectiveness of Acthar® Gel in adults subjects with FSGS who have failed to achieve remission with, or who are intolerant of, 1 or more previous immunosuppressive therapies.

Trial for people with

Primary focal segmental glomerulosclerosis (FSGS)

Study Goal

The purpose of the study is to determine whether H.P. Acthar® Gel (repository corticotropin injection) is helpful for adult patients with FSGS who still have an abnormal amount of protein in their urine, despite prior treatment.

What is involved for the Patient?

If you are enrolled in the study, you will receive Acthar three times a week for 24 weeks as tolerated. After 24 weeks, you will take the study drug twice a week for two weeks. At the end of those two weeks, the study doctor will decide what happens next based on how well your kidneys work after taking the study drug. 

About the drug or intervention

Acthar contains the hormone ACTH, which stands for adrenocorticotropin. Acthar is a gel when refrigerated; at room temperature, it changes to liquid form, ready for injection.

Find other locations for this trial:
Birmingham, AL
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