Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis

PHASE3CompletedINTERVENTIONAL
Enrollment

448

Participants

Timeline

Start Date

July 12, 2012

Primary Completion Date

July 25, 2019

Study Completion Date

March 12, 2020

Conditions
Lupus Nephritis
Interventions
BIOLOGICAL

Placebo plus standard therapy

Placebo plus standard therapy

BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Belimumab 10 mg/kg plus standard therapy

DRUG

Standard therapy

"The standard therapies allowed in this study are:~\- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy~OR~\- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy"

Trial Locations (118)

333

GSK Investigational Site, Gueishan Township,Taoyuan County

1000

GSK Investigational Site, Manila

1090

GSK Investigational Site, Brussels

1200

GSK Investigational Site, Brussels

1425

GSK Investigational Site, Ciudad Autonoma Buenos Aires

3000

GSK Investigational Site, Leuven

3526

GSK Investigational Site, Miskolc

4217

GSK Investigational Site, Lipa City, Batangas

5000

GSK Investigational Site, Córdoba

GSK Investigational Site, Iloilo City

5500

GSK Investigational Site, Mendoza

6000

GSK Investigational Site, Cebu City

6725

GSK Investigational Site, Szeged

7760

GSK Investigational Site, México

8000

GSK Investigational Site, Davao City

8035

GSK Investigational Site, Barcelona

10016

GSK Investigational Site, New York

10032

GSK Investigational Site, New York

10117

GSK Investigational Site, Berlin

10220

GSK Investigational Site, Saimai

10400

GSK Investigational Site, Rajathevee

11021

GSK Investigational Site, Great Neck

11030

GSK Investigational Site, Manhasset

11203

GSK Investigational Site, Brooklyn

14033

GSK Investigational Site, Cean Cedex 09

14080

GSK Investigational Site, México, D.F.

16247

GSK Investigational Site, Suwon

16499

GSK Investigational Site, Suwon-si, Gyeonggi-do

18017

GSK Investigational Site, Bethlehem

19140

GSK Investigational Site, Philadelphia

23538

GSK Investigational Site, Lübeck

27599

GSK Investigational Site, Chapel Hill

29425

GSK Investigational Site, Charleston

30625

GSK Investigational Site, Hanover

31059

GSK Investigational Site, Toulouse

32610

GSK Investigational Site, Gainesville

33136

GSK Investigational Site, Miami

35233

GSK Investigational Site, Daejeon

36200

GSK Investigational Site, Vigo/ Pontevedra

37075

GSK Investigational Site, Göttingen

40002

GSK Investigational Site, Khon Kaen

40705

GSK Investigational Site, Taichung

43203

GSK Investigational Site, Columbus

45040

GSK Investigational Site, Guadalajara

45122

GSK Investigational Site, Essen

46017

GSK Investigational Site, Valencia

48149

GSK Investigational Site, Münster

49201

GSK Investigational Site, Busan

50200

GSK Investigational Site, Muang

54511

GSK Investigational Site, Vandœuvre-lès-Nancy

54650

GSK Investigational Site, Onalaska

55131

GSK Investigational Site, Mainz

58260

GSK Investigational Site, Morelia

59037

GSK Investigational Site, Lille

62170

GSK Investigational Site, Cuernavaca

63110

GSK Investigational Site, St Louis

67091

GSK Investigational Site, Strasbourg

75013

GSK Investigational Site, Paris

79106

GSK Investigational Site, Freiburg im Breisgau

83301

GSK Investigational Site, Kaohsiung City

90502

GSK Investigational Site, Torrance

90623

GSK Investigational Site, La Palma

94010

GSK Investigational Site, Créteil

94578

GSK Investigational Site, San Leandro

100029

GSK Investigational Site, Beijing

110004

GSK Investigational Site, Shenyang

125284

GSK Investigational Site, Moscow

197022

GSK Investigational Site, Saint Petersburg

200025

GSK Investigational Site, Shanghai

200040

GSK Investigational Site, Shanghai

200127

GSK Investigational Site, Shanghai

330006

GSK Investigational Site, Nanchang

350005

GSK Investigational Site, Fuzhou

400038

GSK Investigational Site, Chongqing

410008

GSK Investigational Site, Changsha

430030

GSK Investigational Site, Wuhan

450005

GSK Investigational Site, Ufa

460000

GSK Investigational Site, Orenburg

510080

GSK Investigational Site, Guangzhou

518035

GSK Investigational Site, Shenzhen

530021

GSK Investigational Site, Nanning

610041

GSK Investigational Site, Chengdu

CP 4000

GSK Investigational Site, San Miguel de Tucumán

C1119ACN

GSK Investigational Site, Buenos Aires

C1015ABO

GSK Investigational Site, Ciudad Autonoma Buenos Aires

30150-320

GSK Investigational Site, Belo Horizonte

36010-570

GSK Investigational Site, Juiz de Fora

90035-903

GSK Investigational Site, Porto Alegre

15090-000

GSK Investigational Site, São José do Rio Preto

04039-901

GSK Investigational Site, São Paulo

30150-221

GSK Investigational Site, Belo Horizonte, Minas Gerais

74110-120

GSK Investigational Site, Goiânia

95900-000

GSK Investigational Site, Lajeado

40050-410

GSK Investigational Site, Salvador

T6G 2B7

GSK Investigational Site, Edmonton

H3G 1A4

GSK Investigational Site, Montreal

Unknown

GSK Investigational Site, Xi'an

GSK Investigational Site, Bogotá

GSK Investigational Site, Hong Kong

775 20

GSK Investigational Site, Olomouc

128 08

GSK Investigational Site, Prague

128 50

GSK Investigational Site, Prague

01307

GSK Investigational Site, Dresden

07740

GSK Investigational Site, Jena

9728 NT

GSK Investigational Site, Groningen

2333 ZA

GSK Investigational Site, Leiden

6229 HX

GSK Investigational Site, Maastricht

301-721

GSK Investigational Site, Daejeon

690-767

GSK Investigational Site, Jeju Special Self-Governing Prov.

561-712

GSK Investigational Site, Jeonju

04763

GSK Investigational Site, Seoul

06273

GSK Investigational Site, Seoul

06591

GSK Investigational Site, Seoul

120-752

GSK Investigational Site, Seoul

08025

GSK Investigational Site, Barcelona

07010

GSK Investigational Site, Palma de Mallorca

E1 1BB

GSK Investigational Site, London

SE1 7EH

GSK Investigational Site, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Human Genome Sciences Inc., a GSK Company

INDUSTRY

NCT01639339 - Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis | Biotech Hunter | Biotech Hunter