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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lupus Erythematosus, Systemic; Lupus Nephritis
• Intervention / Treatment: Drug: abetimus sodium (LJP 394) and/or placebo solution; Drug: abetimus sodium (LJP 394); Drug: Phosphate-buffered saline

• Study Type: Interventional
• Enrollment (Actual): 943
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Placebo, normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 to event (12 months fixed treatment duration)

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	12 month fixed treatment duration

Collaborators and Investigators

• Sponsor: La Jolla Pharmaceutical Company
• Investigators: Study Director: Michael J Tansey, MD, Ph.D., Chief Medical Officer, La Jolla Pharmaceutical Company

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: August 13, 2004
• First Submitted That Met QC Criteria: August 16, 2004
• First Posted (Estimate): August 17, 2004

Study Record Updates

• Last Update Posted (Estimate): April 1, 2009
• Last Update Submitted That Met QC Criteria: March 30, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; Nephritis; Kidney; Nephritis, Lupus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Abetimus
• Other Study ID Numbers: LJP 394-90-14