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A Randomized, Open-label Study to Evaluate the Effect of Daprodustat on Blood Pressure in Subjects With Anemia Associated With Chronic Kidney Disease on Hemodialysis Switched From a Stable Dose of an Erythropoiesis-stimulating Agent (NCT03029247)

Quintiles, Inc.
Q2 Solutions
This will be an open-label, randomized, parallel-group study in hemodialysis-dependent (HD) subjects with anemia associated with chronic kidney disease (CKD), designed to compare the effects of daprodustat to epoetin alfa on blood pressure (BP). After a 4-week screening and a 4-week erythropoesis-stimulating agent (ESA) washout period, on Day 1 subjects will be randomized 1:1 and stratified by prior ESA dose before they undergo Acute Challenge 1, a single dose challenge to compare the acute effects on BP of the highest planned once-daily maintenance dose of daprodustat (24 milligrams [mg]) to the highest starting dose of epoetin alfa (100 international units [IU]/kilograms [kg]). This will be followed by an 8-week hemoglobin (Hgb)-maintenance period, where doses of either daprodustat or epoetin alfa will be administered and adjusted. At the end of Hgb maintenance period, on Day 57 an Acute Challenge (number 2) will be repeated utilizing the same treatment as of Acute Challenge 1; there will be a follow-up visit within 14+/-3 days after completing treatment. The total duration of subject involvement is up to 18 weeks (Screening to Follow-up).
  • Drug: Daprodustat
    Daprodustat will be available as 2, 4, 6, 8, and 10 mg oral tablets to be administered once daily
    • Drug: Epoetin alfa
      Epoetin alfa will be administered according to local labelling and clinical practice guidelines to keep Hgb in the target range (10.0-11.0 g/dL)
      Ages eligible for Study
      40 Years and older
      Genders eligible for Study
      Accepts Healthy Volunteers

      7 locations

      United States (7)
      • GSK Investigational Site
        La Mesa, California, United States, 91942
      • GSK Investigational Site
        not yet recruiting
        Lakewood, Colorado, United States, 80228
      • GSK Investigational Site
        not yet recruiting
        Miami, Florida, United States, 33176
      • GSK Investigational Site
        not yet recruiting
        Orlando, Florida, United States, 32809
      • GSK Investigational Site
        not yet recruiting
        Chicago, Illinois, United States, 60643
      • GSK Investigational Site
        Minneapolis, Minnesota, United States, 55404
      • GSK Investigational Site
        not yet recruiting
        San Antonio, Texas, United States, 78215
      17 August, 2017
      01 February, 2018
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