Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
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 PhoneSite 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
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
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 (IgAN)
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.