Last updated on August 2019

Efficacy and Safety Study to Evaluate Vadadustat for the Correction or Maintenance Treatment of Anemia in Subjects With Incident Dialysis-dependent Chronic Kidney Disease (DD-CKD)

Are you eligible to participate in this study?

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

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

Inclusion Criteria:

  • 18 years of age
  • Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
  • Mean Screening hemoglobin between 8.0 and <11.0 g/dL (inclusive)

Exclusion Criteria:

  • Subjects meeting the criteria of ESA resistance within 8 weeks prior to or during Screening defined as follows
    1. epoetin: > 7700 units/dose three times per week or >23,000 units per week
    2. darbepoetin alfa: >100 mcg/week
    3. methoxy polyethylene glycol-epoetin beta: >100 mcg every other week or >200 mcg/month
  • Anemia due to a cause other than CKD or subjects with active bleeding or recent blood loss
  • Anticipated to recover adequate kidney function to no longer require dialysis
  • Uncontrolled hypertension
  • Severe heart failure at Screening (New York Heart Association Class IV)
  • Acute coronary syndrome (hospitalization for unstable angina, 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 CHF; or stroke within 12 weeks prior to or during Screening.
  • Hypersensitivity to vadadustat, darbepoetin alfa or any of their excipients

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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