Last updated on July 2020

Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Anemia | Non-dialysis-dependent Chronic Kidney Disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 18 years of age
  • Diagnosis of CKD with an eGFR 60 mL/min/1.73 m^2 at Screening and not expected to start dialysis within 6 months of Screening
  • Currently maintained on ESA therapy, with a dose received within 6 weeks prior to or during Screening
  • Mean Screening HGB between 8.0 and 11.0 g/dL (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US

Exclusion Criteria:

  • Uncontrolled hypertension
  • Severe heart failure at Screening (New York Heart Association Class IV)
  • Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for HF, or stroke within 12 weeks prior to or during Screening
  • Hypersensitivity to darbepoetin or vadadustat or to any of their excipients

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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