NCT02969655View on ClinicalTrials.gov

A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)

PHASE3CompletedINTERVENTIONAL
Enrollment

271

Participants

Timeline

Start Date

November 21, 2016

Primary Completion Date

July 2, 2018

Study Completion Date

July 2, 2018

Conditions
Anaemia
Interventions
DRUG

Daprodustat small

Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient

DRUG

Daprodustat small placebo

Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat

DRUG

Daprodustat large

Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient

DRUG

Daprodustat large placebo

Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat

DRUG

Darbepoetin alfa

Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution.

DRUG

Darbepoetin alfa placebo

Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution.

Trial Locations (50)

441-8023

GSK Investigational Site, Aichi

446-0053

GSK Investigational Site, Aichi

446-0065

GSK Investigational Site, Aichi

454-0932

GSK Investigational Site, Aichi

455-0021

GSK Investigational Site, Aichi

462-0802

GSK Investigational Site, Aichi

486-8510

GSK Investigational Site, Aichi

276-0031

GSK Investigational Site, Chiba

790-0962

GSK Investigational Site, Ehime

792-0812

GSK Investigational Site, Ehime

918-8503

GSK Investigational Site, Fukui

804-0094

GSK Investigational Site, Fukuoka

811-0120

GSK Investigational Site, Fukuoka

811-0213

GSK Investigational Site, Fukuoka

818-0083

GSK Investigational Site, Fukuoka

963-8002

GSK Investigational Site, Fukushima

963-8071

GSK Investigational Site, Fukushima

370-0615

GSK Investigational Site, Gunma

372-0817

GSK Investigational Site, Gunma

375-0024

GSK Investigational Site, Gunma

004-0814

GSK Investigational Site, Hokkaido

007-0803

GSK Investigational Site, Hokkaido

073-0022

GSK Investigational Site, Hokkaido

073-0196

GSK Investigational Site, Hokkaido

300-0062

GSK Investigational Site, Ibaraki

302-0011

GSK Investigational Site, Ibaraki

305-0861

GSK Investigational Site, Ibaraki

761-8024

GSK Investigational Site, Kagawa

224-0032

GSK Investigational Site, Kanagawa

227-0046

GSK Investigational Site, Kanagawa

234-0054

GSK Investigational Site, Kanagawa

235-0045

GSK Investigational Site, Kanagawa

613-0034

GSK Investigational Site, Kyoto

981-0954

GSK Investigational Site, Miyagi

390-0821

GSK Investigational Site, Nagano

390-1401

GSK Investigational Site, Nagano

399-8292

GSK Investigational Site, Nagano

714-0043

GSK Investigational Site, Okayama

543-0052

GSK Investigational Site, Osaka

547-0024

GSK Investigational Site, Osaka

584-0082

GSK Investigational Site, Osaka

594-0076

GSK Investigational Site, Osaka

348-0045

GSK Investigational Site, Saitama

424-0012

GSK Investigational Site, Shizuoka

158-0094

GSK Investigational Site, Tokyo

169-0075

GSK Investigational Site, Tokyo

930-0065

GSK Investigational Site, Toyama

938-8502

GSK Investigational Site, Toyama

990-0834

GSK Investigational Site, Yamagata

755-0155

GSK Investigational Site, Yamaguchi

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02969655 - A Study to Evaluate Efficacy and Safety of Daprodustat Compared to Darbepoetin Alfa in Japanese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD) | Biotech Hunter | Biotech Hunter