Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

PHASE2TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 10, 2019

Primary Completion Date

May 29, 2019

Study Completion Date

May 29, 2019

Conditions
Anaemia
Interventions
DRUG

Daprodustat

Daprodustat will be available as 1 mg, 2 mg and 4 mg oral tablets. Daprodustat will be administered once daily by oral route without regard for food.

DRUG

Darbepoetin alfa

Darbepoetin alfa will be given as solution for injection for subcutaneous administration every 2 weeks.

DRUG

Acetylcholine

Acetylcholine will be used as a challenge agent and will be infused at 7.5, 15 and 30 micrograms/minute each for 6 minutes per infusion into the brachial artery of the test arm.

DRUG

Sodium nitroprusside

Sodium nitroprusside will be used as a challenge agent and will be infused at 3 and 10 micrograms/minute each for 6 minutes per infusion into the brachial artery of the test arm.

DRUG

L-N-monomethyl arginine acetate (L-NMMA)

L-N-monomethyl arginine acetate will be used as a challenge agent and will be infused at a doses of 2 and 8 micromoles/minute for 6 minutes into the brachial artery of the test arm.

Trial Locations (3)

CB2 0QQ

GSK Investigational Site, Cambridge

EH16 4TJ

GSK Investigational Site, Edinburgh

SE1 7EH

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03446612 - Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF) | Biotech Hunter | Biotech Hunter