Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents

PHASE3CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

August 8, 2016

Primary Completion Date

May 16, 2017

Study Completion Date

October 17, 2017

Conditions
Anaemia
Interventions
DRUG

GSK1278863

GSK1278863 will be provided as round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, 4 mg or 6 mg of GSK1278863 as active ingredient.

DRUG

Iron

Subjects will receive supplemental iron therapy if ferritin is \<=100 ng/mL and TSAT is \<=20%. The investigator (or subinvestigator) will choose the route of administration and dose of prescription iron.

Trial Locations (17)

455-8530

GSK Investigational Site, Aichi

457-8511

GSK Investigational Site, Aichi

802-8555

GSK Investigational Site, Fukuoka

065-8611

GSK Investigational Site, Hokkaido

300-0028

GSK Investigational Site, Ibaraki

302-0022

GSK Investigational Site, Ibaraki

306-0433

GSK Investigational Site, Ibaraki

891-0105

GSK Investigational Site, Kagoshima

861-8520

GSK Investigational Site, Kumamoto

613-0034

GSK Investigational Site, Kyoto

510-8101

GSK Investigational Site, Mie

392-8510

GSK Investigational Site, Nagano

399-8292

GSK Investigational Site, Nagano

555-0001

GSK Investigational Site, Osaka

870-0844

GSK Investigational Site, Ōita

523-0082

GSK Investigational Site, Shiga

990-0834

GSK Investigational Site, Yamagata

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02829320 - Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease Who Are Not Taking Erythropoiesis Stimulating Agents | Biotech Hunter | Biotech Hunter