Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia

PHASE3CompletedINTERVENTIONAL
Enrollment

355

Participants

Timeline

Start Date

June 6, 2016

Primary Completion Date

October 26, 2018

Study Completion Date

October 26, 2018

Conditions
Anaemia
Interventions
DRUG

1 to 4 mg tablets of GSK1278863

7.0 millimeters (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of GSK1278863 as active ingredient, to be orally administered once daily.

DRUG

6 mg GSK1278863 tablet

9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily.

DRUG

Epoetin beta pegol

An injectable formulation containing 25 micrograms µg, 50 µg, 75 µg, 100 µg, 150 µg, 200 µg, or 250 µg of epoetin beta pegol per syringe (0.3 mL), supplied as a glass syringe prefilled with epoetin beta pegol solution (clear colorless to pale yellow). Epoetin beta pegol will be subcutaneously administered once every 2 or 4 weeks.

Trial Locations (56)

453-8566

GSK Investigational Site, Aichi

455-8530

GSK Investigational Site, Aichi

457-8511

GSK Investigational Site, Aichi

486-8510

GSK Investigational Site, Aichi

260-8712

GSK Investigational Site, Chiba

278-0004

GSK Investigational Site, Chiba

790-0024

GSK Investigational Site, Ehime

910-8526

GSK Investigational Site, Fukui

802-8555

GSK Investigational Site, Fukuoka

820-8505

GSK Investigational Site, Fukuoka

963-8052

GSK Investigational Site, Fukushima

500-8523

GSK Investigational Site, Gifu

500-8717

GSK Investigational Site, Gifu

720-0838

GSK Investigational Site, Hiroshima

007-0803

GSK Investigational Site, Hokkaido

060-0033

GSK Investigational Site, Hokkaido

065-8611

GSK Investigational Site, Hokkaido

073-0022

GSK Investigational Site, Hokkaido

073-0196

GSK Investigational Site, Hokkaido

302-0022

GSK Investigational Site, Ibaraki

306-0433

GSK Investigational Site, Ibaraki

310-0015

GSK Investigational Site, Ibaraki

920-0353

GSK Investigational Site, Ishikawa

920-8530

GSK Investigational Site, Ishikawa

890-0073

GSK Investigational Site, Kagoshima

893-0024

GSK Investigational Site, Kagoshima

899-5431

GSK Investigational Site, Kagoshima

210-0852

GSK Investigational Site, Kanagawa

234-8503

GSK Investigational Site, Kanagawa

242-0018

GSK Investigational Site, Kanagawa

251-8550

GSK Investigational Site, Kanagawa

861-8520

GSK Investigational Site, Kumamoto

862-8505

GSK Investigational Site, Kumamoto

604-8845

GSK Investigational Site, Kyoto

611-0041

GSK Investigational Site, Kyoto

612-8555

GSK Investigational Site, Kyoto

396-8555

GSK Investigational Site, Nagano

399-8292

GSK Investigational Site, Nagano

020-0066

GSK Investigational Site, Numakunai

530-0012

GSK Investigational Site, Osaka

530-8480

GSK Investigational Site, Osaka

555-0001

GSK Investigational Site, Osaka

558-8558

GSK Investigational Site, Osaka

586-8521

GSK Investigational Site, Osaka

591-8025

GSK Investigational Site, Osaka

874-0011

GSK Investigational Site, Ōita

330-8553

GSK Investigational Site, Saitama

335-0023

GSK Investigational Site, Saitama

523-0082

GSK Investigational Site, Shiga

425-8505

GSK Investigational Site, Shizuoka

770-0011

GSK Investigational Site, Tokushima

141-8625

GSK Investigational Site, Tokyo

683-0002

GSK Investigational Site, Tottori

932-8503

GSK Investigational Site, Toyama

937-0042

GSK Investigational Site, Toyama

938-8502

GSK Investigational Site, Toyama

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02791763 - Phase III Study of GSK1278863 in Japanese Non-dialysis (ND) and Peritoneal Dialysis (PD) Subjects With Renal Anemia | Biotech Hunter | Biotech Hunter