Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe)

PHASE2CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 30, 2019

Primary Completion Date

July 5, 2022

Study Completion Date

July 5, 2022

Conditions
Anaemia
Interventions
DRUG

Daprodustat

Daprodustat will be available as 1 milligram (mg), 2 mg and 4 mg tablets strengths. One tablet to be taken daily without regard for food.

DRUG

rhEPO

rhEPO (epoetin alfa OR darbepoetin alfa) is commercially available in various single dose vials and single-dose prefilled syringes. It will be given as subcutaneous injection.

DRUG

Ferrous sulfate containing the stable iron isotope (57Fe)

57Fe will be available in oral solution. An oral solution will be administered containing 10 mg of 57Fe as ferrous sulfate.

DRUG

Ferrous sulfate containing the stable iron isotope (58Fe)

58Fe will be available in oral solution. An oral solution will be administered containing 3 mg of 58Fe as ferrous sulfate with 7 mg of 56Fe as ferrous sulfate (natural abundance Fe).

Trial Locations (3)

75904

GSK Investigational Site, Lufkin

76104

GSK Investigational Site, Fort Worth

78212

GSK Investigational Site, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03457701 - Anemia Studies in CKD: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat- Iron (ASCEND: Fe) | Biotech Hunter | Biotech Hunter