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You can access this
clinical trial
if you have
Anaemia
and you are
over 40
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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).

Provided treatments

  • Drug: Daprodustat
  • Drug: Epoetin alfa
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Tris trial is registered with FDA with number: NCT03029247. The sponsor of the trial is GlaxoSmithKline and it is looking for 62 volunteers for the current phase.
Official trial title:
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