drugset / Trial / NCT03029208

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

NCT03029208

Phase 3 Completed 312 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start
2017-05-11
Primary completion
2020-09-24
Completion
2020-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Daprodustat Small molecule 1 mg Oral
Subject Daprodustat Small molecule 2 mg Oral
Subject Daprodustat Small molecule 4 mg Oral
Subject Daprodustat Small molecule 6 mg Oral
Subject Daprodustat Small molecule 8 mg Oral
Subject Daprodustat Small molecule 10 mg Oral
Subject Daprodustat Small molecule 12 mg Oral
Subject Daprodustat Small molecule 16 mg Oral
Subject Daprodustat Small molecule 24 mg Oral
Comparator Darbepoetin alfa Protein / enzyme biologic 20 ug Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 30 ug Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 40 ug Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 60 ug Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 80 ug Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 100 ug Subcutaneous
Comparator Darbepoetin alfa Protein / enzyme biologic 150 ug Subcutaneous

Indications