NCT02876835

Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)

A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,872 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	Daprodustat	The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.
DRUG	Darbepoetin alfa	The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.
DRUG	Placebo	Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
DRUG	Iron Therapy	Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.

Timeline

• Start date: 2016-09-27
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2016-08-24
• Last updated: 2024-04-02
• Results posted: 2022-04-14

Locations

574 sites across 39 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Czechia, Denmark, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study