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Last Updated: October 25, 2021

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CLINICAL TRIALS PROFILE FOR DAPRODUSTAT


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Clinical Trials for Daprodustat

Trial ID Title Status Sponsor Phase Summary
NCT02876835 ↗ Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND) Recruiting GlaxoSmithKline Phase 3 The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
NCT02879305 ↗ Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D) Recruiting GlaxoSmithKline Phase 3 The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
NCT02969655 ↗ A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) Recruiting GlaxoSmithKline Phase 3 Daprodustat is a drug that is currently being developed as a treatment for renal anemia . This study is to evaluate the efficacy and safety of daprodustat following a switch from erythropoiesis-stimulating agent (ESA) in Japanese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of daprodustat to darbepoetin alfa. This study is a 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study. The total duration of the study will be approximately 58 weeks including screening and follow-up.
NCT03029208 ↗ A Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin (rhEPO) in Subjects With Anemia Associated With Chronic Kidney Disease (CKD) Who Are Initiating Dialysis Recruiting GlaxoSmithKline Phase 3 The study will evaluate the safety and efficacy of daprodustat compared to rhEPO for treatment of anemia associated with CKD in subjects who are starting dialysis or who have recently started dialysis. Previous trial in dialysis subjects with anemia associated with CKD demonstrated that daprodustat could maintain hemoglobin up to 24 weeks with minimal effects on plasma erythropoietin (EPO) concentration. Daprodustat is postulated to be associated with fewer major adverse cardiovascular events by raising hemoglobin without the supraphysiologic EPO concentrations associated with intravenous (IV) rhEPO therapy, potentially avoiding blood pressure (BP) elevations and other adverse effects of high EPO levels. This randomized, open-label (sponsor blind) study will comprise three study periods: a screening period of 2 weeks (can be extended by an additional 4 weeks as needed), a 52-week active treatment period, and a follow-up period of 4 to 6 weeks. Approximately 300 subjects or 150 subjects per treatment group will be randomized 1:1 to receive daprodustat or rhEPO (darbepoetin alfa).
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Daprodustat

Condition Name

Condition Name for
Intervention Trials
Anaemia 13
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Condition MeSH

Condition MeSH for
Intervention Trials
Renal Insufficiency, Chronic 9
Anemia 9
Kidney Diseases 8
Liver Diseases 1
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Clinical Trial Locations for Daprodustat

Trials by Country

Trials by Country for
Location Trials
United States 61
United Kingdom 5
Italy 4
Mexico 4
Australia 3
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Trials by US State

Trials by US State for
Location Trials
Virginia 5
California 5
Florida 4
Missouri 4
Texas 4
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Clinical Trial Progress for Daprodustat

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 6
Phase 2 3
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Not yet recruiting 6
Recruiting 6
Completed 1
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Clinical Trial Sponsors for Daprodustat

Sponsor Name

Sponsor Name for
Sponsor Trials
GlaxoSmithKline 13
Quintiles, Q2 Solutions, HemoCue, ERT 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 13
Other 1
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