Study of LJP 394 in Lupus Patients With History of Renal Disease (ASPEN)

This study has been terminated.
(Interim efficacy analysis indicated it would be futile to continue study.)
Sponsor:
Information provided by:
La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier:
NCT00089804
First received: August 13, 2004
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

The primary purpose of this study is to determine whether abetimus sodium is more effective than placebo in delaying time to renal flare in SLE patients with a history of renal disease.


Condition Intervention Phase
Lupus Erythematosus, Systemic
Lupus Nephritis
Drug: abetimus sodium (LJP 394) and/or placebo solution
Drug: abetimus sodium (LJP 394)
Drug: Phosphate-buffered saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

Resource links provided by NLM:


Further study details as provided by La Jolla Pharmaceutical Company:

Primary Outcome Measures:
  • To determine whether abetimus sodium is more effective than placebo in delaying the time to renal flare in SLE patients with a history of SLE renal disease. Weekly administration with a 52-week treatment duration. [ Time Frame: Time to event (12 months fixed treatment duration) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine whether treatment with abetimus sodium is more effective than placebo in delaying the time to Major SLE flare; and to determine whether treatment with abetimus sodium (LJP 394) is more effective than placebo in reducing proteinuria. [ Time Frame: 12 month fixed treatment duration ] [ Designated as safety issue: Yes ]

Enrollment: 943
Study Start Date: October 2004
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly
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
Active Comparator: 2
900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
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.
Placebo Comparator: 3
A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly
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
Other Name: Placebo, normal saline

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Systemic Lupus Erythematosus (SLE)
  • Active SLE renal disease within past 4 years.
  • Males or females between 12 and 70 years old.
  • Females must be non-pregnant and non-lactating. Females and males must use adequate birth control methods during course of study.
  • Ability to have weekly intravenous (IV) administration of study treatment.

Exclusion Criteria:

  • Active SLE renal disease within past 3 months prior to entering study.
  • Use of the following therapies within 3 months prior to entering the study: alkylating agents, e.g., cyclophosphamide, TNF inhibitors, cyclosporine.
  • Use of mycophenolate mofetil that exceeds 1000 mg/day, azathioprine that exceeds 100 mg/day, methotrexate that exceeds 10 mg/week, leflunomide that exceeds 10 mg/day within 2 months prior to entering study.
  • Use of rituximab within 6 months prior to entering study.
  • Current abuse of drugs or alcohol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089804

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Wallace Rheumatic Study Center
Los Angeles, California, United States, 90048
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
Private Practice
San Mateo, California, United States, 94401
United States, Florida
CRIA Research
Fort Lauderdale, Florida, United States, 33334
Miami Children's Hospital
Miami, Florida, United States, 33155
United States, Georgia
Emory University School of Medicine, Renal Division
Atlanta, Georgia, United States, 30322
Private Practice
Augusta, Georgia, United States, 30909
Southeast Regional Research Group
Savannah, Georgia, United States, 31406
United States, Idaho
Intermountain Orthopedics
Boise, Idaho, United States, 83702
United States, Illinois
Rheumatology Associates
Chicago, Illinois, United States, 60612
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
SOMARC Trials, LLC
Greenbelt, Maryland, United States, 20770
United States, New York
Nephrology Associates, PC
Flushing, New York, United States, 11355
North Shore - LIJ Health System
Lake Success, New York, United States, 11042
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases
New York, New York, United States, 10003
AAIR Research Center
Rochester, New York, United States, 14618
Suny Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 27157
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Private Practice
Camp Hill, Pennsylvania, United States, 17011
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
Arthritis Clinic, 371 North Parkway, Suite 400
Jackson, Tennessee, United States, 38305
United States, Texas
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Renal Care Clinic, P.A., 17202 Red Oak Drive
Houston, Texas, United States, 77090
Miracle Medical Clinic, 1170 Blalock Road
Houston, Texas, United States, 77055
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
San Antonio Kidney Disease Center
San Antonio, Texas, United States, 78229
United States, Virginia
Clinical Research & Consulting Center
Fairfax, Virginia, United States, 22030
United States, Washington
Arthritis Northwest PLLC
Spokane, Washington, United States, 99204
Argentina
CIR Hospital Sirio Libanes. Campana 4658
Buenos Aires, Ciudad Autonma de, Argentina, C1419AHN
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Provincia de Tucumán, Argentina, 4000
Instituto CAICI
Rosario, Santa Fe, Argentina, S2000PBJ
Organización Médica de la Investigación
Buenos Aires, Uruguay 725 P.B., Argentina, C1015ABO
Centro de Investigaciones Reumatologicas y Osteologicas
Buenos Aires, Argentina, C11117ABH
Centro de Investigaciones en Enfermedades Reumaticas (CIER)
Buenos Aires, Argentina, C1055AAF
Unidad de Alergia, Asma e Inmunología Clínica
Buenos Aires, Argentina, 1035
Investigación Clínica Polivalente
La Plata, Argentina, 1902
Australia
Rheumatology Clinic
Cairns, Australia, QLD 4870
Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway
St Leonards, Australia, NSW 2065
Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy
Victoria, Australia, 3065 702
Belarus
Gomel Regional Clinical Hospital
Gomel, Belarus, 246029
Minsk City Clinical Hospital # 9
Minsk, Belarus, 220116
Minsk City Clinical Hospital # 2
Minsk, Belarus, 220020
Minsk City Clinical Hospital # 164
Minsk, Belarus, 220113
Minsk Regional Clinical Hospital
Minsk, Belarus, 223040
Vitebsk Regional Clinical Hospital
Vitebsk, Belarus, 210037
Brazil
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul-PUCRS
Porto Alegre-RS, Av. Ipiranga, 6690-Conj. 220-Jardim Botanico, Brazil, 90610-000
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Avenida 28 de Setembro, 77, Brazil, 20.551-030
Hospital Hehopolis
Sao Paulo, Avenida Almirante Delamare, 1534-Sacoman, Brazil, 04230-000
Hospital Geral de Goiania, GO Av Anhanguera 6479 Setor Oeste
Goiania-GO, Goias, Brazil, CEP: 74 110 120
Santa Casa de Misericórdia de BeloHorizonte, Av. Francisco Sales, n. 1111 9 andar Ala D/ CCIH
Belo Horizonte, Minas Gerais, Brazil, CEP: 30150 221
Hospital das Clinicas da Faculdade de Medicina da Universidade, Federal de Goiás, Servico de Reumatologia / 2 andar
Goiänia, Goiás, Primeira Avenida s/n Setor Universitário, Brazil, 74605-020
Hospital de Clinicas - Universidade Estadual de Campinas - UNICAMP, Rua Vital Brasil, 250 - 3º andar - Cidade Universitária Zeferin
Campinas - SP, Brazil, Cep: 13083-888
Hospital e Maternidade Celso Pierro - PUCCampinas, Av. John Boyd Dunlop, s/n
Campinas - Sāo Paulo, Brazil, 13059-740
Athritis Clinica de Doenças Reumaticas, Av. Padre Anchieta, 1846 cj 1108
Curitiba - PR, Brazil, 80730-000
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre-RS, Brazil, 90035-903
Hospital das Clínicas of Medicine School of University of São Paulo (USP) at Ribeirão Preto Rheumatology Department Avenida dos
Ribeirão Preto, Brazil, Cep: 14048-900
Hospital Santa Izabel, Praca Almeida Couto, 500 - Naxaré
Salvador - BA, Brazil, CEP: 40050 410
Irmandade da Santa Casa de Misericórdia de Sāo Paulo Rua, Dr. Cesário Motta Junior, 112
São Paulo, Brazil, Cep: 01221-020
Rua Pedro de Toledo 1800 9 andar/ Ala central - Diretoria de Servico de Reumatologia
Săo Paulo - SP, Brazil, CEP: 04039 004
Bulgaria
NMTranspH "Tsar Boris Treti", Clinic of Internal Diseases
Sofia, 104 "Maria Louisa" blvd., Bulgaria, 1233
MHAT "Stara Zagora", Second Clinic of Internal Diseases
Stara Zagora, 11 "Armeiska" street, Bulgaria, 6000
MHAT "Sveti Ivan Rilski", Clinic of Rheumatology
Sofia, 13 "Urvich" Street, Bulgaria, 1612
MHAT "Sveti Georgi", Clinic of Rheumatology
Plovdiv, 15A "Vasil Aprilov" blvd., Bulgaria, 4002
Military Medical Academy, Clinic of Urology and Nephrology
Sofia, 3, Georgi Sofiiski, str., Bulgaria, 1606
Clinic of Nephrology, MHAT "Alexandrovska" 1, Georgi Sofiiski, str.,
Sofia, Bulgaria, 1431
Czech Republic
Fakultni nemocnice Plzen, Oddeleni klinické farmakologie
Plzen, Edvarda Benese, Czech Republic, 13305 99
VFN Prahal Lékarská fakulta, Klinika detského a dorostového lékarstvi,
Praha 2, Ke Karlovu, 09 Praha 2,, Czech Republic, 2121
Revmatologický ústav
Praha 2, Czech Republic, 128 50
Georgia
Academic VL Tsitlanadze Scientific - Practical Center of Rheumatology
Tbilisi, Georgia, 0102
Germany
Herz and Rheumazentrum Kerckhoff-klinik GmbH
Bad Nauheim, Benekestrasse 2-8, Germany, 61231
Charité-Unversitätmedizin Berlin, CharitéCentrum Inn ere Medizin und Dermatologie
Berlin, Chariteplatz 1, Germany, 10117
Medizinische Klinik und Poliklinik IV des Universitätsklinikum Lepizig, Rheumatologie
Leipzig, Liebigstrasse 22, Germany, 04103
Georg August Universität Göttingen Universitätsklinikum, Zentrum Innere Medizin
Göttingen, Robert-Kochstr. 40, Germany, 37075
Johannes Gutenberg-Universität I. Medizinische Klinik und Poliklinik,Langenbeckstr. 1
Mainz, Germany, 55131
Hong Kong
Hong Kong University, Queen Mary Hospital
Hong Kong, Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, Hong Kong
Hungary
Diagnostic Units Hungary Kft.
Budapest, Hungary, 1036
Szent Margit Hospital, Department of Nephrology
Budapest, Hungary, 1032
Szent László Kórház, VI. Fertőző Belosztály
Budapest, Hungary, 1097
Debrecen Medical University
Debrecen, Hungary, 4004
Petz Aladar Megyei Oktato Korhaz, Immunnephrologia es Hypertonia Osztaly
Gyor, Hungary, 9024
India
Global Hospitals
Hyderabaad, Andhra Pradesh, India, 500 004
Department of Nephrology, All India Institute of Medical Sciences
New Delhi, Ansari Nagar, India, 110029
Institute of Kidney Diseases and Research (IKRD) and Institute of Transplantation Sciences (ITS)
Ahmedabad, Asarwa, India, 380016
Sri Ramachandra Medical College & Research Institute (Deemed University)
Porur, Chennai, India, 600 116
M.P. Shah Medical College & G.G. Hospital
Jamnagar, Gujarat, India, 361001
PVS Memorial Hospital Ltd.
Cochin, Kaloor, Kerala, India, 682017
Apollo Gleneagles Hospital
Kolkatta, Kankurgachi, India, 700054
St. Johns Medical College and Hospital, Dept. of Nephrology
Bangalore, Karnataka, India, 560 034
M.S. Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
Amrita Institute of Medical Sciences
Kochin, Kerala, India, 682026
Consultant and Head Department of Nephrology, Kamineni Hospitals
Hyderabaad, L.B. Nagar, India, 500068
Apollo Specialty Hospitals, Lake View Road, K.K., Nagar
Madurai, Tamil Nadu, India, 625-020
Fortis Hospital, Dept. of Nephrology & Hypertension
Noida, Uttar Pradesh, India
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160 012
Spectra Apollo Research Foundation
Chennai, India
Devaki Hospital Ltd., Dept. of Nephrology
Chennai, India, 600 004
Madras Institute of Nephrology, Vijaya Health Center
Chennai, India, 600 026
Nizams Institute of Medical Sciences
Hyderabaad, India, 500 082
Medwin Hospital
Hyderabaad, India, 500 001
Department of Nephrology, CARE Hospital, Banjara Hills
Hyderabad, India, 500034
Armenian Church Trauma Center - Unit of Rabindranath Tagore International Institute of Cardiac Sciences
Kolkata, India, 700-099
Sanjay Ghandi Post Graduate Institute of Medical Sciences
Lucknow, India, 226014
Seth G.S. Medical College & KEM Hospital
Mumbai, India, 400 012
P.D. Hinduja National Hospital and Research Center
Mumbai, India, 400016
BYL Nair Charitable Hospital & TN Medical College
Mumbai, India, 400 008
Department of Nephrology, JSS Hospital, Ramanuja Road
Mysore, India, 570004
Indraprastha Apollo Hospital
New Delhi, India, 110044
Jehangir Hospital, 32 Sassoon Road
Pune, India, 411001
Medical College Trivandrum
Trivandrum, India, 695011
King George Hospital
Visakhapatnam, India, 530002
Indonesia
Dept. of Internal Medicine, Saiful Anwar General Hospital
Malang, Jl. J.A. Suprapto No. 2, Indonesia, 65111
RS Kramat 128
Jakarta, Jl. Kramat Raya, Pusat, Indonesia, 128
RS Hasan Sadikin
Bandung, Jl. Pasir Kaliki No. 190, Jawa Barat, Indonesia, 40161
Italy
Arcispedale S. Anna, Divisione di Reumatologia
Ferrara, Corso Giovecca 203, Italy, 44100
Azienda Ospedaliera Cattedra di Reumatologia
Padova, Via Giustiniani, 2, Italy, 35128
Universita di Pisa, Dipartimento di Medicina Interna
Pisa, Via Roma 67, Italy, 56126
Korea, Republic of
Ewha Woman's University College of Medicine, Mockdong Hospital
Seoul, Yangcheon-Gu, Korea, Republic of, 158-710
Inha University Hospital
In Cheon, Korea, Republic of, 400-711
Bundang Cha General Hospital, Pochon Cha University
Kyonggi-do, Korea, Republic of, 463-712
Pusan National University Hospital
Pusan, Korea, Republic of, 602-739
Kangnam St. Mary's Hospital, Catholic University of Korea
Seoul, Korea, Republic of, 137-040
The Hospital for Rheumatic Disease, Hanyang University Medical Center
Seoul, Korea, Republic of, 133-792
St. Mary's Hospital, Catholic University of Korea
Seoul, Korea, Republic of, 150-713
Seoul National University Hospital, Department of Internal Medicine
Seoul, Korea, Republic of, 110-744
Ajou University Medical Center, Ajou University School of Medicine
Suwon, Korea, Republic of, 442-721
Lebanon
Rayak Hospital
Rayak, Bekaa Valley, Lebanon
Albert Haykel Hospital
Haykaliyeh-Tripoli, Lebanon
Nabatieh Governmental Hospital
Nabatieh, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Labib Medical Center
Saida, Lebanon
Malaysia
Department of Medicine, Hospital Pulau Pinang,
Pulau Pinang, Jalan Residensi, Malaysia, 10990
CAPD Unit, Queen Elizabeth Hospital,
Sabah, Kota Kinabalu, Malaysia, 88586
Department of Medicine, Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce,
Sarawak, Kuching, Malaysia, 93586
Mexico
Blvd. Sanchez Taboada 9250-28 - Private Practice
Tijuana, Baja California, Mexico, cp22010
Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran", Departmento de inmunologia y Reumatologia
Delagacion Tlalpan, D.f., Mexico, CP 14000
Clínica de Diagnóstico y Tratamiento de las Enfermedades Reumáticas
Mexico City, D.f., Mexico, 06700
Hospital Aranda de la Parra
Leon, Guanajuato, Mexico, CP37000
Centro de Estudios de Investigación Básica y Clínica S.C.
Guadalajara, Jalisco, Mexico, 44690
Colomos #2292, Col. Providencia
Guadalajara, Jalisco, Mexico, 44620
Hospital Star Medica
Morelia, Michoacan, Mexico, 58070
Poliplaza Medica
Chihuahua, Mexico, CP 32500
Reumatologia
Mexicali, Mexico, CP 21100
Hospital Privado San José de Ciudad Obregón, S.A. de C.V. Coahuila No. 263 Sur. Col. Centro. Ciudad Obregón
Sonora, Mexico, C.P. 85000
Philippines
Chung Hua Hospital
Cebu, Philippines, 6000
Davao Doctors Hospital
Davao, Philippines, 8000
Philippine General Hospital
Manila, Philippines, 1000
Joint and Bone Center, University of Santo Tomas Hospital
Manila, Philippines
Poland
Klinika Medycyny, Transplantacyjnej i Nefrologii in Warszawa, Nowogrodzka 59, At SPZOZ Szpital Kliniczny
Warszawa, Dzieciatka Jezus-Centrum Leczenia Obrażeń, Lindleya 4, Poland, 02-005
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych - Akademickie Centrum Kliniczne - Szpital AMG
Gdansk, Poland, 80-952
Klinika Chorob Wewnetrznych i Reumatologii - Gornoslaskie Centrum Medyczne, SPSK Nr 7 SL A M
Katowice, Poland, 40-635
Oddzial Kiliniczny Nefrologii Hipertensjologii i Transplantologii Nerek SPZOZ, Uniwersytecki Szpital Kliniczny nr 1
Lodz, Poland, 90153
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Lublin, Poland, 20-954
Akademii Medycznej w Poznaniu, Zaklad Reumatologii i Immunologii Klinicznej
Poznan, Poland, 61-626
Klinika Chorób Tkanki Łącznej
Warszawa, Poland, 02-637
Klinika Nefrologii Dializoterapii I Chorob Wewnetrznych - Samodzielny Publiczny Centralny Szpital Kliniczny
Warszawa, Poland, 02097
Portugal
Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia
Lisboa, Av. Prof. Egas Moniz, Portugal, 1649-035
Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica
Porto, Largo Prof. Abel Salazar, Portugal, 4099-001
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Rua Conceicao Fernandes, Portugal, 4434-502
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia
Lisboa, Rua da Junqueira, 126, Portugal, 1300
Hospital de Sāo Jeāo, Servico de Nefrologia
Porto, Portugal, 4200-319
Puerto Rico
RCMI Clinical Research Center, 1st Floor University Hospital Medical Center
San Juan, Puerto Rico, 00935
Romania
"Sf. Maria" Clinical Hospital
Bucharest, Romania, 011172
"Ion Stoia" Center of Rheumatic Diseases
Bucharest, Romania, 020983
Emergency Clinical County Hospital Cluj
Cluj Napoca, Romania, 400006
Rehabilitation Clinical Hospital
Iasi, Romania, 700661
Serbia
Institute of Rheumatology
Belgrade, Serbia, 11000
Institute of Nephrology and Urology Clinical Centre of Serbia
Belgrade, Serbia, 11000
University Medical Centre "Zvezdara", Clinical Department for Renal Diseases, Dimitrija Tucovica 161
Belgrade, Serbia, 11000
Institute of Prevention, Treatment and Rehabilitation of Rheumatoid and Cardiovascular Patients "Niska Banja"
Niska Banja, Serbia, 18205
Slovakia
Reumatologicka ambulancia Fakultna nemocnica F D Roosevelta
Banska, Bystrica, Slovakia, 97517
Reumatologicka ambulancia Fakultna nemocnica s poliklinikou Milosrdni bratia spol s r o
Bratislava, Slovakia, 81465
Spain
Hospital Clinic i Provincial de Barcelona, Centre Ciutat, Facultat de Medicina, Servicio de Enfermedades Autoinmunes
Barcelona, Calle Villarroel, 170, Spain, 08036
Hospital Universitario La Paz, Servico de Medicine Interne Planta 10
Madrid, Paseo de la Castellana 261, Spain, 28046
Hospital Universitari Vall d'Hebron, Servicia Medicina Interna, Edificio General, 3a Planta
Barcelona, Paseo Valle de Hebron 119-129, Spain, 08035
Sri Lanka
University Lupus Clinic of the Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No 25,
Colombo, Kynsey Road, Sri Lanka, 08
Taiwan
Buddhist Dalin Tzu Chi General Hospital, Vice Superintendent Room
Dalin Town, Chia-Yi county, Taiwan, 622
Kaohsiung University Medical Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Chang Gung Memorial Hospital
Kaohsiung Hsien, Taiwan, 833
Chang Gung Memorial Hospital - Keelung
Keelung city, Taiwan, 204
China Medical University Hospital
Taichung, Taiwan, 404
Chung Shan Medical University Hospital
Taichung City, Taiwan, 402
National Chang-Kung University Hospital
Tainan, Taiwan
Chang Gung Memorial Hospital - Taipei
Taipei, Taiwan
Taipei Veterans General Hospital - Immunology & Rheumatology Office
Taipei, Taiwan, 112
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Chi Mei Foundation Hospital
Yongkang City, Taiwan
Thailand
Ramathibodi Hospital - Division of Allergy, Immunology & Rheumatology, Dept. of Medicine
Bangkok, Thailand, 10400
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Bangkok, Thailand, 10400
Department of Medicine, King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Ukraine
Donetsk Central Municipal Clinical Hospital #1
Donetsk, Ukraine, 83114
Kyiv Central Municipal Clinical Hospital
Kyiv, Ukraine, 01023
M.D. Strazhesko Institute of Cardiology AMS Ukraine
Kyiv, Ukraine, 03680
Kyiv Regional Clinical Hospital
Kyiv, Ukraine, 04107
Lviv Municipal Public Clinical Hospital
Lviv, Ukraine, 79013
Vinnitsa Regional Clinical Hospital of MoH of Ukraine
Vinnitsa, Ukraine, 21018
Sponsors and Collaborators
La Jolla Pharmaceutical Company
Investigators
Study Director: Michael J Tansey, MD, Ph.D. Chief Medical Officer, La Jolla Pharmaceutical Company
  More Information

Additional Information:
No publications provided

Responsible Party: Michael J. Tansey, Chief Medical Officer, La Jolla Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT00089804     History of Changes
Other Study ID Numbers: LJP 394-90-14
Study First Received: August 13, 2004
Last Updated: March 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by La Jolla Pharmaceutical Company:
Lupus
Nephritis
Kidney
SLE
Systemic Lupus Erythematosus
Nephritis, Lupus

Additional relevant MeSH terms:
Kidney Diseases
Lupus Erythematosus, Systemic
Lupus Nephritis
Nephritis
Urologic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glomerulonephritis

ClinicalTrials.gov processed this record on September 18, 2014