A Prospective, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of Atrasentan, Including Thoracic Bioimpedance, in Type 2 Diabetic Subjects With Nephropathy

Study Identifier
M12-830
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Kidney Disease
  • Study Drug
  • Atrasentan
  • Placebo
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    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 Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 58144
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 71034
    Tempe, Arizona, United States, 85284
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 56927
    Azusa, California, United States, 91702
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 70793
    Azusa, California, United States, 91702
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 64027
    Chula Vista, California, United States, 91910
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 54120
    Concord, California, United States, 94520
    Status
    Not applicable
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