Study of LJP 394 in Lupus Patients With History of Renal Disease
NCT ID: NCT00089804
Last Updated: 2009-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
943 participants
INTERVENTIONAL
2004-10-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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
2
900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
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.
3
A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly
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
Interventions
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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
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
70 Years
ALL
No
Sponsors
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La Jolla Pharmaceutical Company
INDUSTRY
Responsible Party
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La Jolla Pharmaceutical Company
Principal Investigators
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Michael J Tansey, MD, Ph.D.
Role: STUDY_DIRECTOR
Chief Medical Officer, La Jolla Pharmaceutical Company
Locations
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Inha University Hospital
Incheon, , South Korea
Bundang Cha General Hospital, Pochon Cha University
Kyonggi-do, , South Korea
Pusan National University Hospital
Pusan, , South Korea
University of Alabama at Birmingham
Birmingham, Alabama, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
East Bay Rheumatology Medical Group
San Leandro, California, United States
Private Practice
San Mateo, California, United States
CRIA Research
Fort Lauderdale, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Emory University School of Medicine, Renal Division
Atlanta, Georgia, United States
Private Practice
Augusta, Georgia, United States
Southeast Regional Research Group
Savannah, Georgia, United States
Intermountain Orthopedics
Boise, Idaho, United States
Rheumatology Associates
Chicago, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
SOMARC Trials, LLC
Greenbelt, Maryland, United States
Nephrology Associates, PC
Flushing, New York, United States
North Shore - LIJ Health System
Lake Success, New York, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases
New York, New York, United States
AAIR Research Center
Rochester, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
Private Practice
Camp Hill, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Arthritis Clinic, 371 North Parkway, Suite 400
Jackson, Tennessee, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Miracle Medical Clinic, 1170 Blalock Road
Houston, Texas, United States
Renal Care Clinic, P.A., 17202 Red Oak Drive
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
San Antonio Kidney Disease Center
San Antonio, Texas, United States
Clinical Research & Consulting Center
Fairfax, Virginia, United States
Arthritis Northwest PLLC
Spokane, Washington, United States
CIR Hospital Sirio Libanes. Campana 4658
Buenos Aires, Ciudad Autonma de, Argentina
Instituto CAICI
Rosario, Santa Fe Province, Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, Argentina
Organización Médica de la Investigación
Buenos Aires, Uruguay 725 P.B., Argentina
Unidad de Alergia, Asma e Inmunología Clínica
Buenos Aires, , Argentina
Centro de Investigaciones en Enfermedades Reumaticas (CIER)
Buenos Aires, , Argentina
Centro de Investigaciones Reumatologicas y Osteologicas
Buenos Aires, , Argentina
Investigación Clínica Polivalente
La Plata, , Argentina
Rheumatology Clinic
Cairns, , Australia
Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway
St Leonards, , Australia
Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy
Victoria, , Australia
Gomel Regional Clinical Hospital
Homyel, , Belarus
Minsk City Clinical Hospital # 2
Minsk, , Belarus
Minsk City Clinical Hospital # 164
Minsk, , Belarus
Minsk City Clinical Hospital # 9
Minsk, , Belarus
Minsk Regional Clinical Hospital
Minsk, , Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul-PUCRS
Porto Alegre-RS, Av. Ipiranga, 6690-Conj. 220-Jardim Botanico, Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, Avenida 28 de Setembro, 77, Brazil
Hospital Hehopolis
São Paulo, Avenida Almirante Delamare, 1534-Sacoman, Brazil
Hospital Geral de Goiania, GO Av Anhanguera 6479 Setor Oeste
Goiania-GO, Goiás, Brazil
Santa Casa de Misericórdia de BeloHorizonte, Av. Francisco Sales, n. 1111 9 andar Ala D/ CCIH
Belo Horizonte, Minas Gerais, Brazil
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
Hospital e Maternidade Celso Pierro - PUCCampinas, Av. John Boyd Dunlop, s/n
Campinas - Sāo Paulo, , Brazil
Hospital de Clinicas - Universidade Estadual de Campinas - UNICAMP, Rua Vital Brasil, 250 - 3º andar - Cidade Universitária Zeferin
Campinas - SP, , Brazil
Athritis Clinica de Doenças Reumaticas, Av. Padre Anchieta, 1846 cj 1108
Curitiba - PR, , Brazil
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre-RS, , Brazil
Hospital das Clínicas of Medicine School of University of São Paulo (USP) at Ribeirão Preto Rheumatology Department Avenida dos
Ribeirão Preto, , Brazil
Hospital Santa Izabel, Praca Almeida Couto, 500 - Naxaré
Salvador - BA, , Brazil
Irmandade da Santa Casa de Misericórdia de Sāo Paulo Rua, Dr. Cesário Motta Junior, 112
São Paulo, , Brazil
Rua Pedro de Toledo 1800 9 andar/ Ala central - Diretoria de Servico de Reumatologia
Săo Paulo - SP, , Brazil
NMTranspH "Tsar Boris Treti", Clinic of Internal Diseases
Sofia, 104 "Maria Louisa" Blvd., Bulgaria
MHAT "Stara Zagora", Second Clinic of Internal Diseases
Stara Zagora, 11 "Armeiska" Street, Bulgaria
MHAT "Sveti Ivan Rilski", Clinic of Rheumatology
Sofia, 13 "Urvich" Street, Bulgaria
MHAT "Sveti Georgi", Clinic of Rheumatology
Plovdiv, 15A "Vasil Aprilov" Blvd., Bulgaria
Military Medical Academy, Clinic of Urology and Nephrology
Sofia, 3, Georgi Sofiiski, Str., Bulgaria
Clinic of Nephrology, MHAT "Alexandrovska" 1, Georgi Sofiiski, str.,
Sofia, , Bulgaria
Fakultni nemocnice Plzen, Oddeleni klinické farmakologie
Pilsen, Edvarda Benese, Czechia
VFN Prahal Lékarská fakulta, Klinika detského a dorostového lékarstvi,
Prague, Ke Karlovu, 09 Praha 2,, Czechia
Revmatologický ústav
Prague, , Czechia
Academic VL Tsitlanadze Scientific - Practical Center of Rheumatology
Tbilisi, , Georgia
Herz and Rheumazentrum Kerckhoff-klinik GmbH
Bad Nauheim, Benekestrasse 2-8, Germany
Charité-Unversitätmedizin Berlin, CharitéCentrum Inn ere Medizin und Dermatologie
Berlin, Chariteplatz 1, Germany
Medizinische Klinik und Poliklinik IV des Universitätsklinikum Lepizig, Rheumatologie
Leipzig, Liebigstrasse 22, Germany
Georg August Universität Göttingen Universitätsklinikum, Zentrum Innere Medizin
Göttingen, Robert-Kochstr. 40, Germany
Johannes Gutenberg-Universität I. Medizinische Klinik und Poliklinik,Langenbeckstr. 1
Mainz, , Germany
Hong Kong University, Queen Mary Hospital
Hong Kong, , Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong, , Hong Kong
Szent Margit Hospital, Department of Nephrology
Budapest, , Hungary
Diagnostic Units Hungary Kft.
Budapest, , Hungary
Szent László Kórház, VI. Fertőző Belosztály
Budapest, , Hungary
Debrecen Medical University
Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz, Immunnephrologia es Hypertonia Osztaly
Győr, , Hungary
Global Hospitals
Hyderabaad, Andhra Pradesh, India
Department of Nephrology, All India Institute of Medical Sciences
New Delhi, Ansari Nagar, India
Institute of Kidney Diseases and Research (IKRD) and Institute of Transplantation Sciences (ITS)
Ahmedabad, Asarwa, India
Sri Ramachandra Medical College & Research Institute (Deemed University)
Porur, Chennai, India
M.P. Shah Medical College & G.G. Hospital
Jamnagar, Gujarat, India
PVS Memorial Hospital Ltd.
Kochi, Kaloor, Kerala, India
Apollo Gleneagles Hospital
Kolkata, Kankurgachi, India
St. Johns Medical College and Hospital, Dept. of Nephrology
Bangalore, Karnataka, India
M.S. Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Consultant and Head Department of Nephrology, Kamineni Hospitals
Hyderabaad, L.B. Nagar, India
Apollo Specialty Hospitals, Lake View Road, K.K., Nagar
Madurai, Tamil Nadu, India
Fortis Hospital, Dept. of Nephrology & Hypertension
Noida, Uttar Pradesh, India
Post Graduate Institute of Medical Education and Research
Chandigarh, , India
Devaki Hospital Ltd., Dept. of Nephrology
Chennai, , India
Madras Institute of Nephrology, Vijaya Health Center
Chennai, , India
Spectra Apollo Research Foundation
Chennai, , India
Medwin Hospital
Hyderabaad, , India
Nizams Institute of Medical Sciences
Hyderabaad, , India
Department of Nephrology, CARE Hospital, Banjara Hills
Hyderabad, , India
Armenian Church Trauma Center - Unit of Rabindranath Tagore International Institute of Cardiac Sciences
Kolkata, , India
Sanjay Ghandi Post Graduate Institute of Medical Sciences
Lucknow, , India
BYL Nair Charitable Hospital & TN Medical College
Mumbai, , India
Seth G.S. Medical College & KEM Hospital
Mumbai, , India
P.D. Hinduja National Hospital and Research Center
Mumbai, , India
Department of Nephrology, JSS Hospital, Ramanuja Road
Mysore, , India
Indraprastha Apollo Hospital
New Delhi, , India
Jehangir Hospital, 32 Sassoon Road
Pune, , India
Medical College Trivandrum
Trivandrum, , India
King George Hospital
Visakhapatnam, , India
Dept. of Internal Medicine, Saiful Anwar General Hospital
Malang, Jl. J.A. Suprapto No. 2, Indonesia
RS Kramat 128
Jakarta, Jl. Kramat Raya, Pusat, Indonesia
RS Hasan Sadikin
Bandung, Jl. Pasir Kaliki No. 190, Jawa Barat, Indonesia
Arcispedale S. Anna, Divisione di Reumatologia
Ferrara, Corso Giovecca 203, Italy
Azienda Ospedaliera Cattedra di Reumatologia
Padua, Via Giustiniani, 2, Italy
Universita di Pisa, Dipartimento di Medicina Interna
Pisa, Via Roma 67, Italy
Rayak Hospital
Riyaq, 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
Department of Medicine, Hospital Pulau Pinang,
Pulau Pinang, Jalan Residensi, Malaysia
CAPD Unit, Queen Elizabeth Hospital,
Sabak Bernam, Kota Kinabalu, Malaysia
Department of Medicine, Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce,
Sarawak, Kuching, Malaysia
Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran", Departmento de inmunologia y Reumatologia
Delagacion Tlalpan, D.F., Mexico
Clínica de Diagnóstico y Tratamiento de las Enfermedades Reumáticas
Mexico City, D.F., Mexico
Blvd. Sanchez Taboada 9250-28 - Private Practice
Tijuana, Estado de Baja California, Mexico
Hospital Aranda de la Parra
León, Guanajuato, Mexico
Colomos #2292, Col. Providencia
Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigación Básica y Clínica S.C.
Guadalajara, Jalisco, Mexico
Hospital Star Medica
Morelia, Michoacán, Mexico
Poliplaza Medica
Chihuahua City, , Mexico
Reumatologia
Mexicali, , Mexico
Hospital Privado San José de Ciudad Obregón, S.A. de C.V. Coahuila No. 263 Sur. Col. Centro. Ciudad Obregón
Sonora, , Mexico
Chung Hua Hospital
Cebu, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Philippine General Hospital
Manila, , Philippines
Joint and Bone Center, University of Santo Tomas Hospital
Manila, , Philippines
Klinika Medycyny, Transplantacyjnej i Nefrologii in Warszawa, Nowogrodzka 59, At SPZOZ Szpital Kliniczny
Warsaw, Dzieciatka Jezus-Centrum Leczenia Obrażeń, Lindleya 4, Poland
Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych - Akademickie Centrum Kliniczne - Szpital AMG
Gdansk, , Poland
Klinika Chorob Wewnetrznych i Reumatologii - Gornoslaskie Centrum Medyczne, SPSK Nr 7 SL A M
Katowice, , Poland
Oddzial Kiliniczny Nefrologii Hipertensjologii i Transplantologii Nerek SPZOZ, Uniwersytecki Szpital Kliniczny nr 1
Lodz, , Poland
Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
Lublin, , Poland
Akademii Medycznej w Poznaniu, Zaklad Reumatologii i Immunologii Klinicznej
Poznan, , Poland
Klinika Chorób Tkanki Łącznej
Warsaw, , Poland
Klinika Nefrologii Dializoterapii I Chorob Wewnetrznych - Samodzielny Publiczny Centralny Szpital Kliniczny
Warsaw, , Poland
Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia
Lisbon, Av. Prof. Egas Moniz, Portugal
Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica
Porto, Largo Prof. Abel Salazar, Portugal
Centro Hospitalar de Vila Nova de Gaia
Vila Nova de Gaia, Rua Conceicao Fernandes, Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia
Lisbon, Rua Da Junqueira, 126, Portugal
Hospital de Sāo Jeāo, Servico de Nefrologia
Porto, , Portugal
RCMI Clinical Research Center, 1st Floor University Hospital Medical Center
San Juan, , Puerto Rico
"Sf. Maria" Clinical Hospital
Bucharest, , Romania
"Ion Stoia" Center of Rheumatic Diseases
Bucharest, , Romania
Emergency Clinical County Hospital Cluj
Cluj-Napoca, , Romania
Rehabilitation Clinical Hospital
Iași, , Romania
Institute of Nephrology and Urology Clinical Centre of Serbia
Belgrade, , Serbia
Institute of Rheumatology
Belgrade, , Serbia
University Medical Centre "Zvezdara", Clinical Department for Renal Diseases, Dimitrija Tucovica 161
Belgrade, , Serbia
Institute of Prevention, Treatment and Rehabilitation of Rheumatoid and Cardiovascular Patients "Niska Banja"
Niška Banja, , Serbia
Reumatologicka ambulancia Fakultna nemocnica F D Roosevelta
Banska, Bystrica, Slovakia
Reumatologicka ambulancia Fakultna nemocnica s poliklinikou Milosrdni bratia spol s r o
Bratislava, , Slovakia
Ewha Woman's University College of Medicine, Mockdong Hospital
Seoul, Yangcheon-Gu, South Korea
Seoul National University Hospital, Department of Internal Medicine
Seoul, , South Korea
The Hospital for Rheumatic Disease, Hanyang University Medical Center
Seoul, , South Korea
Kangnam St. Mary's Hospital, Catholic University of Korea
Seoul, , South Korea
St. Mary's Hospital, Catholic University of Korea
Seoul, , South Korea
Ajou University Medical Center, Ajou University School of Medicine
Suwon, , South Korea
Hospital Clinic i Provincial de Barcelona, Centre Ciutat, Facultat de Medicina, Servicio de Enfermedades Autoinmunes
Barcelona, Calle Villarroel, 170, Spain
Hospital Universitario La Paz, Servico de Medicine Interne Planta 10
Madrid, Paseo de La Castellana 261, Spain
Hospital Universitari Vall d'Hebron, Servicia Medicina Interna, Edificio General, 3a Planta
Barcelona, Paseo Valle de Hebron 119-129, Spain
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
Buddhist Dalin Tzu Chi General Hospital, Vice Superintendent Room
Dalin Town, Chia-Yi County, Taiwan
Kaohsiung University Medical Hospital
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital
Kaohsiung Hsien, , Taiwan
Chang Gung Memorial Hospital - Keelung
Keelung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Chang-Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital - Immunology & Rheumatology Office
Taipei, , Taiwan
Chang Gung Memorial Hospital - Taipei
Taipei, , Taiwan
Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Chi Mei Foundation Hospital
Yongkang District, , Taiwan
Department of Medicine, King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Ramathibodi Hospital - Division of Allergy, Immunology & Rheumatology, Dept. of Medicine
Bangkok, , Thailand
Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
Bangkok, , Thailand
Donetsk Central Municipal Clinical Hospital #1
Donetsk, , Ukraine
Kyiv Central Municipal Clinical Hospital
Kyiv, , Ukraine
M.D. Strazhesko Institute of Cardiology AMS Ukraine
Kyiv, , Ukraine
Kyiv Regional Clinical Hospital
Kyiv, , Ukraine
Lviv Municipal Public Clinical Hospital
Lviv, , Ukraine
Vinnitsa Regional Clinical Hospital of MoH of Ukraine
Vinnitsa, , Ukraine
Countries
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Related Links
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Sponsor's website
Other Identifiers
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LJP 394-90-14
Identifier Type: -
Identifier Source: org_study_id
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