Study of LJP 394 in Lupus Patients With History of Renal Disease (ASPEN)
Lupus Erythematosus, Systemic, Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham
- Wallace Rheumatic Study Center
- East Bay Rheumatology Medical Group
- Private Practice
- CRIA Research
- Miami Children's Hospital
- Emory University School of Medicine, Renal Division
- Private Practice
- Southeast Regional Research Group
- Intermountain Orthopedics
- Rheumatology Associates
- Ochsner Clinic Foundation
- SOMARC Trials, LLC
- Nephrology Associates, PC
- North Shore - LIJ Health System
- Feinstein Institute for Medical Research
- Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases
- AAIR Research Center
- Suny Upstate Medical University
- Wake Forest University Health Sciences
- Ohio State University Medical Center
- Healthcare Research Consultants
- Private Practice
- Altoona Center for Clinical Research
- Arthritis Clinic, 371 North Parkway, Suite 400
- Amarillo Center for Clinical Research
- Miracle Medical Clinic, 1170 Blalock Road
- Renal Care Clinic, P.A., 17202 Red Oak Drive
- Texas Tech University Health Sciences Center
- San Antonio Kidney Disease Center
- Clinical Research & Consulting Center
- Arthritis Northwest PLLC
- CIR Hospital Sirio Libanes. Campana 4658
- Centro de Investigaciones Reumatológicas
- Instituto CAICI
- Organización Médica de la Investigación
- Unidad de Alergia, Asma e Inmunología Clínica
- Centro de Investigaciones en Enfermedades Reumaticas (CIER)
- Centro de Investigaciones Reumatologicas y Osteologicas
- Investigación Clínica Polivalente
- Rheumatology Clinic
- Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway
- Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy
- Gomel Regional Clinical Hospital
- Minsk City Clinical Hospital # 2
- Minsk City Clinical Hospital # 164
- Minsk City Clinical Hospital # 9
- Minsk Regional Clinical Hospital
- Vitebsk Regional Clinical Hospital
- Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul-PUCRS
- Hospital Universitario Pedro Ernesto
- Hospital Hehopolis
- Hospital Geral de Goiania, GO Av Anhanguera 6479 Setor Oeste
- Santa Casa de Misericórdia de BeloHorizonte, Av. Francisco Sales, n. 1111 9 andar Ala D/ CCIH
- Hospital das Clinicas da Faculdade de Medicina da Universidade, Federal de Goiás, Servico de Reumatologia / 2 andar
- Hospital de Clinicas - Universidade Estadual de Campinas - UNICAMP, Rua Vital Brasil, 250 - 3º andar - Cidade Universitária Zeferin
- Hospital e Maternidade Celso Pierro - PUCCampinas, Av. John Boyd Dunlop, s/n
- Athritis Clinica de Doenças Reumaticas, Av. Padre Anchieta, 1846 cj 1108
- Hospital de Clinicas de Porto Alegre - HCPA
- Hospital das Clínicas of Medicine School of University of São Paulo (USP) at Ribeirão Preto Rheumatology Department Avenida dos
- Hospital Santa Izabel, Praca Almeida Couto, 500 - Naxaré
- Irmandade da Santa Casa de Misericórdia de Sāo Paulo Rua, Dr. Cesário Motta Junior, 112
- Rua Pedro de Toledo 1800 9 andar/ Ala central - Diretoria de Servico de Reumatologia
- NMTranspH "Tsar Boris Treti", Clinic of Internal Diseases
- MHAT "Stara Zagora", Second Clinic of Internal Diseases
- MHAT "Sveti Ivan Rilski", Clinic of Rheumatology
- MHAT "Sveti Georgi", Clinic of Rheumatology
- Military Medical Academy, Clinic of Urology and Nephrology
- Clinic of Nephrology, MHAT "Alexandrovska" 1, Georgi Sofiiski, str.,
- Fakultni nemocnice Plzen, Oddeleni klinické farmakologie
- VFN Prahal Lékarská fakulta, Klinika detského a dorostového lékarstvi,
- Revmatologický ústav
- Academic VL Tsitlanadze Scientific - Practical Center of Rheumatology
- Herz and Rheumazentrum Kerckhoff-klinik GmbH
- Charité-Unversitätmedizin Berlin, CharitéCentrum Inn ere Medizin und Dermatologie
- Medizinische Klinik und Poliklinik IV des Universitätsklinikum Lepizig, Rheumatologie
- Georg August Universität Göttingen Universitätsklinikum, Zentrum Innere Medizin
- Johannes Gutenberg-Universität I. Medizinische Klinik und Poliklinik,Langenbeckstr. 1
- Hong Kong University, Queen Mary Hospital
- The Chinese University of Hong Kong, Prince of Wales Hospital
- Szent Margit Hospital, Department of Nephrology
- Diagnostic Units Hungary Kft.
- Szent László Kórház, VI. Fertőző Belosztály
- Debrecen Medical University
- Petz Aladar Megyei Oktato Korhaz, Immunnephrologia es Hypertonia Osztaly
- Global Hospitals
- Department of Nephrology, All India Institute of Medical Sciences
- Institute of Kidney Diseases and Research (IKRD) and Institute of Transplantation Sciences (ITS)
- Sri Ramachandra Medical College & Research Institute (Deemed University)
- M.P. Shah Medical College & G.G. Hospital
- PVS Memorial Hospital Ltd.
- Apollo Gleneagles Hospital
- St. Johns Medical College and Hospital, Dept. of Nephrology
- M.S. Ramaiah Memorial Hospital
- Amrita Institute of Medical Sciences
- Consultant and Head Department of Nephrology, Kamineni Hospitals
- Apollo Specialty Hospitals, Lake View Road, K.K., Nagar
- Fortis Hospital, Dept. of Nephrology & Hypertension
- Post Graduate Institute of Medical Education and Research
- Devaki Hospital Ltd., Dept. of Nephrology
- Madras Institute of Nephrology, Vijaya Health Center
- Spectra Apollo Research Foundation
- Medwin Hospital
- Nizams Institute of Medical Sciences
- Department of Nephrology, CARE Hospital, Banjara Hills
- Armenian Church Trauma Center - Unit of Rabindranath Tagore International Institute of Cardiac Sciences
- Sanjay Ghandi Post Graduate Institute of Medical Sciences
- BYL Nair Charitable Hospital & TN Medical College
- Seth G.S. Medical College & KEM Hospital
- P.D. Hinduja National Hospital and Research Center
- Department of Nephrology, JSS Hospital, Ramanuja Road
- Indraprastha Apollo Hospital
- Jehangir Hospital, 32 Sassoon Road
- Medical College Trivandrum
- King George Hospital
- Dept. of Internal Medicine, Saiful Anwar General Hospital
- RS Kramat 128
- RS Hasan Sadikin
- Arcispedale S. Anna, Divisione di Reumatologia
- Azienda Ospedaliera Cattedra di Reumatologia
- Universita di Pisa, Dipartimento di Medicina Interna
- Ewha Woman's University College of Medicine, Mockdong Hospital
- Inha University Hospital
- Bundang Cha General Hospital, Pochon Cha University
- Pusan National University Hospital
- Seoul National University Hospital, Department of Internal Medicine
- The Hospital for Rheumatic Disease, Hanyang University Medical Center
- Kangnam St. Mary's Hospital, Catholic University of Korea
- St. Mary's Hospital, Catholic University of Korea
- Ajou University Medical Center, Ajou University School of Medicine
- Rayak Hospital
- Albert Haykel Hospital
- Nabatieh Governmental Hospital
- Hammoud Hospital University Medical Center
- Labib Medical Center
- Department of Medicine, Hospital Pulau Pinang,
- CAPD Unit, Queen Elizabeth Hospital,
- Department of Medicine, Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce,
- Blvd. Sanchez Taboada 9250-28 - Private Practice
- Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran", Departmento de inmunologia y Reumatologia
- Clínica de Diagnóstico y Tratamiento de las Enfermedades Reumáticas
- Hospital Aranda de la Parra
- Colomos #2292, Col. Providencia
- Centro de Estudios de Investigación Básica y Clínica S.C.
- Hospital Star Medica
- Poliplaza Medica
- Reumatologia
- Hospital Privado San José de Ciudad Obregón, S.A. de C.V. Coahuila No. 263 Sur. Col. Centro. Ciudad Obregón
- Chung Hua Hospital
- Davao Doctors Hospital
- Philippine General Hospital
- Joint and Bone Center, University of Santo Tomas Hospital
- Klinika Medycyny, Transplantacyjnej i Nefrologii in Warszawa, Nowogrodzka 59, At SPZOZ Szpital Kliniczny
- Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych - Akademickie Centrum Kliniczne - Szpital AMG
- Klinika Chorob Wewnetrznych i Reumatologii - Gornoslaskie Centrum Medyczne, SPSK Nr 7 SL A M
- Oddzial Kiliniczny Nefrologii Hipertensjologii i Transplantologii Nerek SPZOZ, Uniwersytecki Szpital Kliniczny nr 1
- Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej
- Akademii Medycznej w Poznaniu, Zaklad Reumatologii i Immunologii Klinicznej
- Klinika Chorób Tkanki Łącznej
- Klinika Nefrologii Dializoterapii I Chorob Wewnetrznych - Samodzielny Publiczny Centralny Szpital Kliniczny
- Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia
- Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica
- Centro Hospitalar de Vila Nova de Gaia
- Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia
- Hospital de Sāo Jeāo, Servico de Nefrologia
- RCMI Clinical Research Center, 1st Floor University Hospital Medical Center
- "Sf. Maria" Clinical Hospital
- "Ion Stoia" Center of Rheumatic Diseases
- Emergency Clinical County Hospital Cluj
- Rehabilitation Clinical Hospital
- Institute of Nephrology and Urology Clinical Centre of Serbia
- Institute of Rheumatology
- University Medical Centre "Zvezdara", Clinical Department for Renal Diseases, Dimitrija Tucovica 161
- Institute of Prevention, Treatment and Rehabilitation of Rheumatoid and Cardiovascular Patients "Niska Banja"
- Reumatologicka ambulancia Fakultna nemocnica F D Roosevelta
- Reumatologicka ambulancia Fakultna nemocnica s poliklinikou Milosrdni bratia spol s r o
- Hospital Clinic i Provincial de Barcelona, Centre Ciutat, Facultat de Medicina, Servicio de Enfermedades Autoinmunes
- Hospital Universitario La Paz, Servico de Medicine Interne Planta 10
- Hospital Universitari Vall d'Hebron, Servicia Medicina Interna, Edificio General, 3a Planta
- University Lupus Clinic of the Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No 25,
- Buddhist Dalin Tzu Chi General Hospital, Vice Superintendent Room
- Chang Gung Memorial Hospital
- Kaohsiung University Medical Hospital
- Kaohsiung Veterans General Hospital
- Chang Gung Memorial Hospital - Keelung
- Chung Shan Medical University Hospital
- China Medical University Hospital
- National Chang-Kung University Hospital
- Taipei Veterans General Hospital - Immunology & Rheumatology Office
- Chang Gung Memorial Hospital - Taipei
- Chang Gung Memorial Hospital
- Chi Mei Foundation Hospital
- Department of Medicine, King Chulalongkorn Memorial Hospital
- Ramathibodi Hospital - Division of Allergy, Immunology & Rheumatology, Dept. of Medicine
- Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine
- Donetsk Central Municipal Clinical Hospital #1
- Kyiv Central Municipal Clinical Hospital
- M.D. Strazhesko Institute of Cardiology AMS Ukraine
- Kyiv Regional Clinical Hospital
- Lviv Municipal Public Clinical Hospital
- Vinnitsa Regional Clinical Hospital of MoH of Ukraine
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
1
2
3
300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly
900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
A volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly