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:
La Jolla Pharmaceutical Company
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089804
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| 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 May 19, 2013