A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)

PHASE2CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

May 1, 2015

Study Completion Date

June 15, 2015

Conditions
Anaemia
Interventions
DRUG

GSK1278863

Film-coated tablets containing 0.5 mg, 1 mg, 2 mg, 5mg or matching placebo

DRUG

rhEPO

Locally sourced rhEPO. All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered..

Trial Locations (123)

1036

GSK Investigational Site, Budapest

1097

GSK Investigational Site, Budapest

1115

GSK Investigational Site, Budapest

1135

GSK Investigational Site, Budapest

2145

GSK Investigational Site, Westmead

2170

GSK Investigational Site, Liverpool

5000

GSK Investigational Site, Adelaide

GSK Investigational Site, Odense C

6009

GSK Investigational Site, Nedlands

8000

GSK Investigational Site, Székesfehérvár

12053

GSK Investigational Site, Berlin

14004

GSK Investigational Site, Córdoba

14033

GSK Investigational Site, Caen

15401

GSK Investigational Site, Uniontown

15706

GSK Investigational Site, Santiago de Compostela

17109

GSK Investigational Site, Demmin

18014

GSK Investigational Site, Granada

18017

GSK Investigational Site, Bethlehem

22297

GSK Investigational Site, Hamburg

28041

GSK Investigational Site, Madrid

28224

GSK Investigational Site, Madrid

28702

GSK Investigational Site, San Sebastián de los Reyes

28805

GSK Investigational Site, Alcalá de Henares

31217

GSK Investigational Site, Macon

31406

GSK Investigational Site, Savannah

33000

GSK Investigational Site, Bordeaux

33028

GSK Investigational Site, Pembroke Pines

33150

GSK Investigational Site, Miami

33313

GSK Investigational Site, Lauderdale Lakes

37923

GSK Investigational Site, Knoxville

39008

GSK Investigational Site, Santander

40210

GSK Investigational Site, Düsseldorf

60805

GSK Investigational Site, Evergreen Park

63640

GSK Investigational Site, Farmington

68167

GSK Investigational Site, Mannheim

69110

GSK Investigational Site, Sainte-Foy-lès-Lyon

69437

GSK Investigational Site, Lyon

71101

GSK Investigational Site, Shreveport

75110

GSK Investigational Site, Corsicana

75743

GSK Investigational Site, Paris

76508

GSK Investigational Site, Temple

78229

GSK Investigational Site, San Antonio

80054

GSK Investigational Site, Amiens

81675

GSK Investigational Site, Munich

84112

GSK Investigational Site, Salt Lake City

85381

GSK Investigational Site, Peoria

89081

GSK Investigational Site, Ulm

90022

GSK Investigational Site, Los Angeles

90025

GSK Investigational Site, Los Angeles

91307

GSK Investigational Site, West Hills

91702

GSK Investigational Site, Azusa

91773

GSK Investigational Site, San Dimas

91942

GSK Investigational Site, La Mesa

92103

GSK Investigational Site, San Diego

92653

GSK Investigational Site, Laguna Hills

94010

GSK Investigational Site, Créteil

119121

GSK Investigational Site, Moscow

125101

GSK Investigational Site, Moscow

150062

GSK Investigational Site, Yaroslavl

197110

GSK Investigational Site, Saint Petersburg

248007

GSK Investigational Site, Kaluga

350029

GSK Investigational Site, Krasnodar

426063

GSK Investigational Site, Izhevsk

432063

GSK Investigational Site, Ulyanovsk

628012

GSK Investigational Site, Khantymansiysk

660062

GSK Investigational Site, Krasnoyarsk

Unknown

GSK Investigational Site, Charlotte

T6G 2B7

GSK Investigational Site, Edmonton

L6T 0G1

GSK Investigational Site, Brampton

P3E 5J1

GSK Investigational Site, Greater Sudbury

N2G 1E8

GSK Investigational Site, Kitchener

N6A 5A5

GSK Investigational Site, London

L5M 2V8

GSK Investigational Site, Mississauga

H1T 2M4

GSK Investigational Site, Montreal

H9R 4S3

GSK Investigational Site, Pointe-Claire

350 02

GSK Investigational Site, Cheb

460 63

GSK Investigational Site, Liberec

440 01

GSK Investigational Site, Louny

353 01

GSK Investigational Site, Mariánské Lázně

434 64

GSK Investigational Site, Most

100 34

GSK Investigational Site, Prague

128 08

GSK Investigational Site, Prague

142 00

GSK Investigational Site, Prague

356 01

GSK Investigational Site, Sokolov

DK-4000

GSK Investigational Site, Roskilde

04129

GSK Investigational Site, Leipzig

455-8530

GSK Investigational Site, Aichi

500-8717

GSK Investigational Site, Gifu

370-0001

GSK Investigational Site, Gunma

302-0014

GSK Investigational Site, Ibaraki

302-0022

GSK Investigational Site, Ibaraki

210-0852

GSK Investigational Site, Kanagawa

604-8845

GSK Investigational Site, Kyoto

388-8004

GSK Investigational Site, Nagano

558-8558

GSK Investigational Site, Osaka

523-0082

GSK Investigational Site, Shiga

31-501

GSK Investigational Site, Krakow

20-081

GSK Investigational Site, Lublin

33-100

GSK Investigational Site, Tarnów

02-507

GSK Investigational Site, Warsaw

41-800

GSK Investigational Site, Zabrze

431-070

GSK Investigational Site, Anyang-Si Gyeonggi-do

700-721

GSK Investigational Site, Daegu

301-721

GSK Investigational Site, Daejeon

501-757

GSK Investigational Site, Gwangju

08916

GSK Investigational Site, Badalona

08011

GSK Investigational Site, Barcelona

08035

GSK Investigational Site, Barcelona

08907

GSK Investigational Site, Barcelona

SE-413 45

GSK Investigational Site, Gothenburg

SE-651 85

GSK Investigational Site, Karlstad

SE-701 85

GSK Investigational Site, Örebro

SE-141 86

GSK Investigational Site, Stockholm

SE-751 85

GSK Investigational Site, Uppsala

CM1 7ET

GSK Investigational Site, Chelmsford

DT1 2JY

GSK Investigational Site, Dorchester

DD1 9SY

GSK Investigational Site, Dundee

HU3 2JZ

GSK Investigational Site, Hull

LS9 7TF

GSK Investigational Site, Leeds

E1 1BB

GSK Investigational Site, London

NW3 2QG

GSK Investigational Site, London

M13 9WL

GSK Investigational Site, Manchester

OX3 7LE

GSK Investigational Site, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01977573 - A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD) | Biotech Hunter | Biotech Hunter