Prospective, Randomized, Double-Blind, Parallel Design, Placebo-Controlled Multicenter Study. The study objectives are to evaluate efficacy and safety, including thoracic bioimpedance, of once daily administration of atrasentan tablets (high dose and low dose) compared to placebo in type 2 diabetic subjects with nephropathy who are receiving the maximum tolerated labeled daily dose of a RAS inhibitor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
Site Reference ID/Investigator# 58144
Phoenix, Arizona, United States
Site Reference ID/Investigator# 71034
Tempe, Arizona, United States
Site Reference ID/Investigator# 56927
Azusa, California, United States
Site Reference ID/Investigator# 70793
Azusa, California, United States
Site Reference ID/Investigator# 64027
Chula Vista, California, United States
Change from baseline to each post-baseline visit up to Week 8 in log-transformed Urinary Albumin to Creatinine Ratio (UACR)
Time frame: Every two weeks for 8 weeks
Change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR)
Time frame: Every two weeks for 8 weeks
The change from baseline to each post-baseline assessment of thoracic bioimpedance
Time frame: Treatment Day 1, Week 1, 2, 4, 6, 8 and 30 days post-treatment
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Site Reference ID/Investigator# 54120
Concord, California, United States
Site Reference ID/Investigator# 64026
La Mesa, California, United States
Site Reference ID/Investigator# 70173
Los Angeles, California, United States
Site Reference ID/Investigator# 54121
Denver, Colorado, United States
Site Reference ID/Investigator# 56924
Boynton Beach, Florida, United States
...and 18 more locations