Study Of Diabetic Nephropathy With Atrasentan

Study Identifier
M11-352
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English

Study Details

Medical Condition
  • Kidney Disease
  • Study Drug
  • Atrasentan
  • Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 85 Years

    Protocol Summary

    The study objective was to evaluate the effect of atrasentan compared with placebo on time to doubling of serum creatinine (DBSC) or the onset of end-stage renal disease (ESRD) in participants with type 2 diabetes and nephropathy who were treated with the maximum tolerated labeled daily dose (MTLDD) of a renin-angiotensin system (RAS) inhibitor. In addition, the study assessed the effects of atrasentan compared with placebo on cardiovascular (CV) morbidity and mortality, urine albumin excretion, changes in estimated glomerular filtration rate (eGFR), as well as the impact on quality of life in participants with type 2 diabetes and nephropathy.

    Study Locations

    No locations found.