The main objective of this trial is the safety and tolerability of 3 multiple rising oral doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important diagnostic marker of nephropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
Taken orally
Taken orally
Nephrology Consultants, LLC
Huntsville, Alabama, United States
California Institute of Renal Research
La Mesa, California, United States
Office of Dr. Richard S. Cherlin
Los Gatos, California, United States
Creekside Endocrine Associates, PC
Denver, Colorado, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
Percentage of patients with drug related Adverse Events (AEs)
Time frame: Up to 35 days
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in morning void urine
Time frame: Up to 28 days
Change from baseline in log transformed Urine albumin creatinine ratio (UACR) measured in 10-hour urine
Time frame: Up to 28 days
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The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Ocean Blue Medical Research Center, Inc.
Miami Springs, Florida, United States
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