SONAR: Study Of Diabetic Nephropathy with Atrasentan
Study Name: A Randomized, Multicountry, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy – SONAR: Study Of Diabetic Nephropathy with Atrasentan
Principal Investigator: Karen Hall, M.D.
Study Coordinator: Danielle Poulton
What is the SONAR Study?
The purpose of this study is to assess the effects of the investigational compound atrasentan, compared with placebo, on renal outcomes in patients with type 2 diabetic nephropathy (diabetic kidney disease) who are treated with the maximum tolerated labeled daily dose (MTLDD) of a Renin-Angiotensin System (RAS) inhibitor. In addition, the study will evaluate atrasentan’s impact on renal outcomes, such as the onset of end-stage renal disease (ESRD), cardiovascular morbidity and mortality, as well as on the impact on quality of life in subjects with type 2 diabetes and nephropathy.
Who Can Participate?
Volunteers who meet the following criteria and who are willing and able to independently give written informed consent will be considered for participation in this study:
- Be between the ages of 18 – 85
- Have diagnosed type 2 diabetes with nephropathy (diabetic kidney disease)
- Have been treated with at least one anti-hyperglycemic medication and ACEi/or ARB (RAS inhibitor) for at least 3 months prior to the screening period.
What do I have to do as a participant?
Eligible participants will visit the UF & Shands Family Medicine at Main Street clinic in Gainesville, FL. Following initial screening and enrichment visits, participants will have a total of 19 scheduled office visits over the course of 48 months, depending on when you enter the study, with scheduled phone calls occurring every 3 months through study end. Subjects will receive standard care through duration of the trial.