At a glance
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A 52-week, Phase III, Double-blind, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease Who Are Currently ESA Users
In Brief
A Phase 3 clinical trial evaluating Daprodustat small, Daprodustat small placebo, and 4 other interventions for Anaemia. Completed, enrolled 271 participants across 50 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient
Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat
Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient
Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat
Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution.
Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution.