The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.
The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Unnamed facility
Tempe, Arizona, United States
Unnamed facility
Buena Park, California, United States
Measure: change from baseline in 24-hour urinary ACR for each arm compared with placebo
Time frame: 6 months
Measure: Safety and tolerability of FG-3019 in the study population.
Time frame: 12 months
Measure: Change from baseline in eGFR for each FG-3019 arm compared to placebo
Time frame: 6 months
Measure: Change from baseline in serum creatinine for each FG-3019 arm compared with placebo
Time frame: 6 months
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Unnamed facility
Lakewood, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Walnut Creek, California, United States
Unnamed facility
Whittier, California, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Evergreen Park, Illinois, United States
Unnamed facility
Topeka, Kansas, United States
Unnamed facility
Wichita, Kansas, United States
...and 18 more locations