Study of LJP 394 in Lupus Patients With History of Renal Disease

PHASE3TerminatedINTERVENTIONAL
Enrollment

943

Participants

Timeline

Start Date

October 31, 2004

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Lupus Erythematosus, SystemicLupus Nephritis
Interventions
DRUG

abetimus sodium (LJP 394) and/or placebo solution

300 mg (50 mg/mL)abetimus sodium (three 2 mL vials of of abetimus sodium plus six 2 mL vials of normal saline) administered i.v. (in the vien) weekly for 52 weeks

DRUG

abetimus sodium (LJP 394)

900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.

DRUG

Phosphate-buffered saline

A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks

Trial Locations (201)

112

Taipei Veterans General Hospital - Immunology & Rheumatology Office, Taipei

128

RS Kramat 128, Jakarta

204

Chang Gung Memorial Hospital - Keelung, Keelung

402

Chung Shan Medical University Hospital, Taichung

404

China Medical University Hospital, Taichung

622

Buddhist Dalin Tzu Chi General Hospital, Vice Superintendent Room, Dalin Town

807

Kaohsiung University Medical Hospital, Kaohsiung City

813

Kaohsiung Veterans General Hospital, Kaohsiung City

833

Chang Gung Memorial Hospital, Kaohsiung Hsien

1000

Philippine General Hospital, Manila

1032

Szent Margit Hospital, Department of Nephrology, Budapest

1035

Unidad de Alergia, Asma e Inmunología Clínica, Buenos Aires

1036

Diagnostic Units Hungary Kft., Budapest

1097

Szent László Kórház, VI. Fertőző Belosztály, Budapest

1233

"NMTranspH Tsar Boris Treti, Clinic of Internal Diseases", Sofia

1300

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia, Lisbon

1431

"Clinic of Nephrology, MHAT Alexandrovska 1, Georgi Sofiiski, str.,", Sofia

1606

Military Medical Academy, Clinic of Urology and Nephrology, Sofia

1612

"MHAT Sveti Ivan Rilski, Clinic of Rheumatology", Sofia

1902

Investigación Clínica Polivalente, La Plata

2121

VFN Prahal Lékarská fakulta, Klinika detského a dorostového lékarstvi,, Prague

4000

Centro de Investigaciones Reumatológicas, San Miguel de Tucumán

4002

"MHAT Sveti Georgi, Clinic of Rheumatology", Plovdiv

4004

Debrecen Medical University, Debrecen

6000

"MHAT Stara Zagora, Second Clinic of Internal Diseases", Stara Zagora

Chung Hua Hospital, Cebu

8000

Davao Doctors Hospital, Davao City

9024

Petz Aladar Megyei Oktato Korhaz, Immunnephrologia es Hypertonia Osztaly, Győr

10003

Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases, New York

10117

Charité-Unversitätmedizin Berlin, CharitéCentrum Inn ere Medizin und Dermatologie, Berlin

10330

Department of Medicine, King Chulalongkorn Memorial Hospital, Bangkok

10400

Ramathibodi Hospital - Division of Allergy, Immunology & Rheumatology, Dept. of Medicine, Bangkok

Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine, Bangkok

10990

Department of Medicine, Hospital Pulau Pinang,, Pulau Pinang

11000

Institute of Nephrology and Urology Clinical Centre of Serbia, Belgrade

Institute of Rheumatology, Belgrade

"University Medical Centre Zvezdara, Clinical Department for Renal Diseases, Dimitrija Tucovica 161", Belgrade

11030

Feinstein Institute for Medical Research, Manhasset

11042

North Shore - LIJ Health System, Lake Success

11355

Nephrology Associates, PC, Flushing

13210

Suny Upstate Medical University, Syracuse

14618

AAIR Research Center, Rochester

16635

Altoona Center for Clinical Research, Duncansville

17011

Private Practice, Camp Hill

18205

"Institute of Prevention, Treatment and Rehabilitation of Rheumatoid and Cardiovascular Patients Niska Banja", Niška Banja

20770

SOMARC Trials, LLC, Greenbelt

21018

Vinnitsa Regional Clinical Hospital of MoH of Ukraine, Vinnitsa

22030

Clinical Research & Consulting Center, Fairfax

27157

Wake Forest University Health Sciences, Winston-Salem

28046

Hospital Universitario La Paz, Servico de Medicine Interne Planta 10, Madrid

30322

Emory University School of Medicine, Renal Division, Atlanta

30909

Private Practice, Augusta

31406

Southeast Regional Research Group, Savannah

33155

Miami Children's Hospital, Miami

33334

CRIA Research, Fort Lauderdale

35128

Azienda Ospedaliera Cattedra di Reumatologia, Padua

35294

University of Alabama at Birmingham, Birmingham

37075

Georg August Universität Göttingen Universitätsklinikum, Zentrum Innere Medizin, Göttingen

38305

Arthritis Clinic, 371 North Parkway, Suite 400, Jackson

40161

RS Hasan Sadikin, Bandung

43210

Ohio State University Medical Center, Columbus

44100

Arcispedale S. Anna, Divisione di Reumatologia, Ferrara

44620

Colomos #2292, Col. Providencia, Guadalajara

44690

Centro de Estudios de Investigación Básica y Clínica S.C., Guadalajara

55131

Johannes Gutenberg-Universität I. Medizinische Klinik und Poliklinik,Langenbeckstr. 1, Mainz

56126

Universita di Pisa, Dipartimento di Medicina Interna, Pisa

58070

Hospital Star Medica, Morelia

60612

Rheumatology Associates, Chicago

61231

Herz and Rheumazentrum Kerckhoff-klinik GmbH, Bad Nauheim

65111

Dept. of Internal Medicine, Saiful Anwar General Hospital, Malang

70121

Ochsner Clinic Foundation, New Orleans

74135

Healthcare Research Consultants, Tulsa

77055

Miracle Medical Clinic, 1170 Blalock Road, Houston

77090

Renal Care Clinic, P.A., 17202 Red Oak Drive, Houston

78229

San Antonio Kidney Disease Center, San Antonio

79013

Lviv Municipal Public Clinical Hospital, Lviv

79124

Amarillo Center for Clinical Research, Amarillo

79430

Texas Tech University Health Sciences Center, Lubbock

81465

Reumatologicka ambulancia Fakultna nemocnica s poliklinikou Milosrdni bratia spol s r o, Bratislava

83114

Donetsk Central Municipal Clinical Hospital #1, Donetsk

83702

Intermountain Orthopedics, Boise

88586

CAPD Unit, Queen Elizabeth Hospital,, Sabak Bernam

90048

Wallace Rheumatic Study Center, Los Angeles

90153

Oddzial Kiliniczny Nefrologii Hipertensjologii i Transplantologii Nerek SPZOZ, Uniwersytecki Szpital Kliniczny nr 1, Lodz

93586

Department of Medicine, Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce,, Sarawak

94401

Private Practice, San Mateo

94578

East Bay Rheumatology Medical Group, San Leandro

97517

Reumatologicka ambulancia Fakultna nemocnica F D Roosevelta, Banska

99204

Arthritis Northwest PLLC, Spokane

110029

Department of Nephrology, All India Institute of Medical Sciences, New Delhi

110044

Indraprastha Apollo Hospital, New Delhi

210037

Vitebsk Regional Clinical Hospital, Vitebsk

220020

Minsk City Clinical Hospital # 2, Minsk

220113

Minsk City Clinical Hospital # 164, Minsk

220116

Minsk City Clinical Hospital # 9, Minsk

223040

Minsk Regional Clinical Hospital, Minsk

226014

Sanjay Ghandi Post Graduate Institute of Medical Sciences, Lucknow

246029

Gomel Regional Clinical Hospital, Homyel

361001

M.P. Shah Medical College & G.G. Hospital, Jamnagar

380016

Institute of Kidney Diseases and Research (IKRD) and Institute of Transplantation Sciences (ITS), Ahmedabad

400006

Emergency Clinical County Hospital Cluj, Cluj-Napoca

400016

P.D. Hinduja National Hospital and Research Center, Mumbai

411001

Jehangir Hospital, 32 Sassoon Road, Pune

500034

Department of Nephrology, CARE Hospital, Banjara Hills, Hyderabad

500068

Consultant and Head Department of Nephrology, Kamineni Hospitals, Hyderabaad

530002

King George Hospital, Visakhapatnam

560054

M.S. Ramaiah Memorial Hospital, Bangalore

570004

Department of Nephrology, JSS Hospital, Ramanuja Road, Mysore

682017

PVS Memorial Hospital Ltd., Kochi

682026

Amrita Institute of Medical Sciences, Kochi

695011

Medical College Trivandrum, Trivandrum

700054

Apollo Gleneagles Hospital, Kolkata

700661

Rehabilitation Clinical Hospital, Iași

C1419AHN

CIR Hospital Sirio Libanes. Campana 4658, Buenos Aires

S2000PBJ

Instituto CAICI, Rosario

C1015ABO

Organización Médica de la Investigación, Buenos Aires

C1055AAF

Centro de Investigaciones en Enfermedades Reumaticas (CIER), Buenos Aires

C11117ABH

Centro de Investigaciones Reumatologicas y Osteologicas, Buenos Aires

QLD 4870

Rheumatology Clinic, Cairns

NSW 2065

Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway, St Leonards

3065 702

Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy, Victoria

90610-000

Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul-PUCRS, Porto Alegre-RS

20.551-030

Hospital Universitario Pedro Ernesto, Rio de Janeiro

04230-000

Hospital Hehopolis, São Paulo

CEP: 74 110 120

Hospital Geral de Goiania, GO Av Anhanguera 6479 Setor Oeste, Goiania-GO

CEP: 30150 221

Santa Casa de Misericórdia de BeloHorizonte, Av. Francisco Sales, n. 1111 9 andar Ala D/ CCIH, Belo Horizonte

74605-020

Hospital das Clinicas da Faculdade de Medicina da Universidade, Federal de Goiás, Servico de Reumatologia / 2 andar, Goiänia, Goiás

13059-740

Hospital e Maternidade Celso Pierro - PUCCampinas, Av. John Boyd Dunlop, s/n, Campinas - Sāo Paulo

Cep: 13083-888

Hospital de Clinicas - Universidade Estadual de Campinas - UNICAMP, Rua Vital Brasil, 250 - 3º andar - Cidade Universitária Zeferin, Campinas - SP

80730-000

Athritis Clinica de Doenças Reumaticas, Av. Padre Anchieta, 1846 cj 1108, Curitiba - PR

90035-903

Hospital de Clinicas de Porto Alegre - HCPA, Porto Alegre-RS

Cep: 14048-900

Hospital das Clínicas of Medicine School of University of São Paulo (USP) at Ribeirão Preto Rheumatology Department Avenida dos, Ribeirão Preto

CEP: 40050 410

Hospital Santa Izabel, Praca Almeida Couto, 500 - Naxaré, Salvador - BA

Cep: 01221-020

Irmandade da Santa Casa de Misericórdia de Sāo Paulo Rua, Dr. Cesário Motta Junior, 112, São Paulo

CEP: 04039 004

Rua Pedro de Toledo 1800 9 andar/ Ala central - Diretoria de Servico de Reumatologia, Săo Paulo - SP

13305 99

Fakultni nemocnice Plzen, Oddeleni klinické farmakologie, Pilsen

128 50

Revmatologický ústav, Prague

0102

Academic VL Tsitlanadze Scientific - Practical Center of Rheumatology, Tbilisi

04103

Medizinische Klinik und Poliklinik IV des Universitätsklinikum Lepizig, Rheumatologie, Leipzig

Unknown

Hong Kong University, Queen Mary Hospital, Hong Kong

The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong

Fortis Hospital, Dept. of Nephrology & Hypertension, Noida

Spectra Apollo Research Foundation, Chennai

Rayak Hospital, Riyaq

Albert Haykel Hospital, Haykaliyeh-Tripoli

Nabatieh Governmental Hospital, Nabatieh

Hammoud Hospital University Medical Center, Saida

Labib Medical Center, Saida

Joint and Bone Center, University of Santo Tomas Hospital, Manila

National Chang-Kung University Hospital, Tainan City

Chang Gung Memorial Hospital - Taipei, Taipei

Chang Gung Memorial Hospital, Taoyuan District

Chi Mei Foundation Hospital, Yongkang District

500 004

Global Hospitals, Hyderabaad

600 116

Sri Ramachandra Medical College & Research Institute (Deemed University), Porur

560 034

St. Johns Medical College and Hospital, Dept. of Nephrology, Bangalore

625-020

Apollo Specialty Hospitals, Lake View Road, K.K., Nagar, Madurai

160 012

Post Graduate Institute of Medical Education and Research, Chandigarh

600 004

Devaki Hospital Ltd., Dept. of Nephrology, Chennai

600 026

Madras Institute of Nephrology, Vijaya Health Center, Chennai

500 001

Medwin Hospital, Hyderabaad

500 082

Nizams Institute of Medical Sciences, Hyderabaad

700-099

Armenian Church Trauma Center - Unit of Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata

400 008

BYL Nair Charitable Hospital & TN Medical College, Mumbai

400 012

Seth G.S. Medical College & KEM Hospital, Mumbai

CP 14000

"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Departmento de inmunologia y Reumatologia", Delagacion Tlalpan

06700

Clínica de Diagnóstico y Tratamiento de las Enfermedades Reumáticas, Mexico City

cp22010

Blvd. Sanchez Taboada 9250-28 - Private Practice, Tijuana

CP37000

Hospital Aranda de la Parra, León

CP 32500

Poliplaza Medica, Chihuahua City

CP 21100

Reumatologia, Mexicali

C.P. 85000

Hospital Privado San José de Ciudad Obregón, S.A. de C.V. Coahuila No. 263 Sur. Col. Centro. Ciudad Obregón, Sonora

02-005

Klinika Medycyny, Transplantacyjnej i Nefrologii in Warszawa, Nowogrodzka 59, At SPZOZ Szpital Kliniczny, Warsaw

80-952

Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych - Akademickie Centrum Kliniczne - Szpital AMG, Gdansk

40-635

Klinika Chorob Wewnetrznych i Reumatologii - Gornoslaskie Centrum Medyczne, SPSK Nr 7 SL A M, Katowice

20-954

Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej, Lublin

61-626

Akademii Medycznej w Poznaniu, Zaklad Reumatologii i Immunologii Klinicznej, Poznan

02-637

Klinika Chorób Tkanki Łącznej, Warsaw

02097

Klinika Nefrologii Dializoterapii I Chorob Wewnetrznych - Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw

1649-035

Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia, Lisbon

4099-001

Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica, Porto

4434-502

Centro Hospitalar de Vila Nova de Gaia, Vila Nova de Gaia

4200-319

Hospital de Sāo Jeāo, Servico de Nefrologia, Porto

00935

RCMI Clinical Research Center, 1st Floor University Hospital Medical Center, San Juan

011172

"Sf. Maria Clinical Hospital", Bucharest

020983

"Ion Stoia Center of Rheumatic Diseases", Bucharest

158-710

Ewha Woman's University College of Medicine, Mockdong Hospital, Seoul

400-711

Inha University Hospital, Incheon

463-712

Bundang Cha General Hospital, Pochon Cha University, Kyonggi-do

602-739

Pusan National University Hospital, Pusan

110-744

Seoul National University Hospital, Department of Internal Medicine, Seoul

133-792

The Hospital for Rheumatic Disease, Hanyang University Medical Center, Seoul

137-040

Kangnam St. Mary's Hospital, Catholic University of Korea, Seoul

150-713

St. Mary's Hospital, Catholic University of Korea, Seoul

442-721

Ajou University Medical Center, Ajou University School of Medicine, Suwon

08036

Hospital Clinic i Provincial de Barcelona, Centre Ciutat, Facultat de Medicina, Servicio de Enfermedades Autoinmunes, Barcelona

08035

Hospital Universitari Vall d'Hebron, Servicia Medicina Interna, Edificio General, 3a Planta, Barcelona

08

University Lupus Clinic of the Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No 25,, Colombo

01023

Kyiv Central Municipal Clinical Hospital, Kyiv

03680

M.D. Strazhesko Institute of Cardiology AMS Ukraine, Kyiv

04107

Kyiv Regional Clinical Hospital, Kyiv

All Listed Sponsors
lead

La Jolla Pharmaceutical Company

INDUSTRY

NCT00089804 - Study of LJP 394 in Lupus Patients With History of Renal Disease | Biotech Hunter | Biotech Hunter