Last updated on August 2019

A Phase IIA Study of Blood Pressure Comparing Daprodustat to an Erythropoiesis-stimulating Agent in Subjects With Anemia of Chronic Kidney Disease on Hemodialysis


Brief description of study

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). Subjects will be screened for eligibility within 7 and 30 days prior to erythropoesis-stimulating agent (ESA) washout. Following a 2-week 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 dose administered in 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 16 weeks (Screening to Follow-up).

Clinical Study Identifier: NCT03029247

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