A Study of Atrasentan on Reducing Albuminuria in Type 2 Diabetic Nephropathy Treated With Renin-Angiotensin System Inhibitors

Study Identifier
M10-815
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
  • Placebo for Atrasentan 0.2 mg/mL solution
  • 0.25 mg Atrasentan QD
  • 0.75 mg Atrasentan QD
  • 1.75 mg Atrasentan QD
  • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The study objective is to investigate the effects of three low doses of atrasentan on urinary albumin/creatinine ratio (UACR) levels in subjects with Type 2 diabetic nephropathy.

    Patients with Type 2 diabetes with nephropathy must be receiving a renin-angiotensin system inhibitor, such as an Angiotensin converting enzyme inhibitor (ACEi) or an Angiotensin II Receptor Blocker (ARB) for participation in this study. ACEi and ARB treatment are the standard of care for the management of proteinuria in Chronic Kidney Disease (CKD) patients.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 19386
    Tempe, Arizona, United States, 85284
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 25043
    Azusa, California, United States, 91702
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 23308
    Los Angeles, California, United States, 90022
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 25430
    Los Angeles, California, United States, 90048
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 20421
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 22442
    San Diego, California, United States, 92123
    Status
    Not applicable
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