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Currently Enrolling
Interventional

ASSIST

A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodiumglucose Cotransporter-2 Inhibitors (SGLT2i).

Brief Description

A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2 inhibitor.

Trial Physician / Study Coordinator

Amy Bottomlee

Email Phone (205) 975-4482
Site Name

University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC) - Nephrology Clinic
701 20th Street South, Birmingham, AL, 35294

Sponsor

Chinook Therapeutics, a Novartis Company

Study Drug

Atrasentan

Estimated enrollment

52

Estimated end date

Jan 2025

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

ASSIST

A Randomized, Double-blind, Placebo-controlled, Crossover Study of Atrasentan in Subjects with IgA Nephropathy on Sodiumglucose Cotransporter-2 Inhibitors (SGLT2i).

Brief Description

A study to learn if atrasentan is safe and works in people with IgA nephropathy who are taking an SGLT2 inhibitor.

Trial is for people with

IgA nephopathy

Study Goal

ASSIST seeks to evaluate the efficacy of atrasentan vs placebo while on background therapy with SGLT2i

What is involved for the Patient?

This is a phase 2, double-blind, placebo-controlled, crossover study. All the participants will take all the study treatments (atrasentan and a placebo), but in a different order. Participants will take study treatment for up to 36 weeks but will be in the study for up to 64 weeks. Participants must already be taking an SGLT2i before joining the study or be willing to start taking an SGLT2i during the study. Participants will complete up to 14 study site visits and up to 11 remote visits. Both atrasentan and the placebo are taken as tablets by mouth. Participants will continue to take an SGLT2i throughout the entire study. During the study, the study doctors will monitor the participants’ health by testing their blood and urine, performing physical exams and checking their heart function with an electrocardiogram.

About the drug or intervention

The study drug, atrasentan, is designed to work by blocking a specific pathway in the kidneys, preventing it from causing negative effects that damage the kidneys. Blocking this pathway may help to prevent kidney damage and may even help the kidneys work better. All participants in this study will also be taking an SGLT2 inhibitor (SGLT2i). An SGLT2i is a drug that is used to treat chronic kidney disease. Chronic kidney disease is a condition in which the kidneys stop working over time due to kidney damage. Researchers think that giving atrasentan with an SGLT2i could prevent kidney damage over time.

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.

 

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