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 evaluate whether or not atrasentan is effective in delaying the worsening of kidney disease by comparing the time to serum creatinine doubling or the onset of end stage renal disease in subjects with type 2 diabetes and kidney disease. Another purpose of this study is to test the safety of atrasentan.
In addition, this study will compare atrasentan with a placebo to see if taking atrasentan is better than taking a placebo. The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.
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.