NCT03029208

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-in Incident Dialysis (ASCEND-ID)

A 52-week Open-label (Sponsor-blind), Randomized, Active-controlled, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of Daprodustat Compared to Recombinant Human Erythropoietin in Subjects With Anemia Associated With Chronic Kidney Disease Who Are Initiating Dialysis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this multi-center study is to evaluate the efficacy and safety of daprodustat in subjects with anemia associated with CKD.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	Daprodustat	Daprodustat will be supplied as film coated tablets for oral administration containing 1, 2, 4, 6, 8, or 10 mg of daprodustat. Doses of 12, 16, and 24 mg of daprodustat will be provided using multiples of these tablet strengths.
DRUG	Darbepoetin alfa	Darbepoetin alfa will be supplied as prefilled syringes (PFS) for SC/IV injection available in strengths: 20, 30, 40, 60, 80, 100 and 150 mcg.
DRUG	Iron therapy	Iron therapy will be administered if ferritin is \<=100 ng/mL and/or TSAT is \<=20%.

Timeline

• Start date: 2017-05-11
• Primary completion: 2020-09-24
• Completion: 2020-09-24
• First posted: 2017-01-24
• Last updated: 2021-10-20
• Results posted: 2021-10-20

Locations

111 sites across 15 countries: United States, Argentina, Australia, Canada, Germany, India, Italy, Malaysia, Mexico, Poland, Russia, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study