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Currently Enrolling
Interventional

R3R01: AS-FSGS

R3R01: AS-FSGS

Brief Description

A Phase II, Multi-center, Open-Label Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of R3R01 in Alport Syndrome Patients with uncontrolled Proteinuria on ACE/ARB Inhibition, and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis.

Trial Physician / Study Coordinator

Czerr Jennifer

Email
Site Name

Cleveland Clinic
9500 Euclid Ave Cleveland, Ohio, 44195

Sponsor

R3R Corp

Study Drug

R3R01

Estimated enrollment

20 AS and 30 FSGS patients

Estimated end date

Last patient enrolled July 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.
Currently Enrolling
Interventional

R3R01: AS-FSGS

R3R01: AS-FSGS

Brief Description

A Phase II, Multi-center, Open-Label Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of R3R01 in Alport Syndrome Patients with uncontrolled Proteinuria on ACE/ARB Inhibition, and in Patients with Primary Steroid-Resistant Focal Segmental Glomerulosclerosis.

Trial is for people with

Alport syndrome and primary focal segmental glomerulosclerosis (FSGS)

Study Goal

The goal of this 12-week open-label study is to determine if R3R01 reduces proteinuria.

What is involved for the Patient?

All patients will receive R3R01 as an oral tablet twice daily for 12 weeks. Blood and urine will be collected, physical exams including vital signs and electrocardiograms will be performed. Patients will be required to attend study visits weekly for the first month, then monthly for the remainder of treatment and 3-month follow-up.

About the drug or intervention

R3R01 is an orally administered small molecule that targets a novel mechanism by increasing levels of functional ABCA1 and cholesterol efflux with the aim of reducing pathologic levels of intracellular (kidney) lipids.

Cleveland, OH
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