AzTrials
AzTrials

Lupus Erythematosus, SystemicPhase 3ASPENNCT00089804

Study of LJP 394 in Lupus Patients With History of Renal Disease

A Phase 3 study testing abetimus sodium (LJP 394) and Phosphate-buffered saline in people with Lupus Erythematosus, Systemic and Lupus Nephritis, run by La Jolla Pharmaceutical Company at 201 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 70 years
What is being tested?
abetimus sodium (LJP 394) and Phosphate-buffered saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
943 participants
Where
201 sitesin 30 countries
Study dates
Oct 2004to Feb 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

201 sites in 30 countries.

201 sites in 30 countries

United States32 sites

  • Amarillo Center for Clinical Research

    Amarillo, Texas, 79124

  • Emory University School of Medicine, Renal Division

    Atlanta, Georgia, 30322

  • Private Practice

    Augusta, Georgia, 30909

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Intermountain Orthopedics

    Boise, Idaho, 83702

  • Private Practice

    Camp Hill, Pennsylvania, 17011

  • Rheumatology Associates

    Chicago, Illinois, 60612

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Clinical Research & Consulting Center

    Fairfax, Virginia, 22030

  • Nephrology Associates, PC

    Flushing, New York, 11355

  • CRIA Research

    Fort Lauderdale, Florida, 33334

  • SOMARC Trials, LLC

    Greenbelt, Maryland, 20770

  • Miracle Medical Clinic, 1170 Blalock Road

    Houston, Texas, 77055

  • Renal Care Clinic, P.A., 17202 Red Oak Drive

    Houston, Texas, 77090

  • Arthritis Clinic, 371 North Parkway, Suite 400

    Jackson, Tennessee, 38305

  • North Shore - LIJ Health System

    Lake Success, New York, 11042

  • Wallace Rheumatic Study Center

    Los Angeles, California, 90048

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Seligman Center for Advanced Therapeutics, NYU Hospital for Joint Diseases

    New York, New York, 10003

  • AAIR Research Center

    Rochester, New York, 14618

  • San Antonio Kidney Disease Center

    San Antonio, Texas, 78229

  • East Bay Rheumatology Medical Group

    San Leandro, California, 94578

  • Private Practice

    San Mateo, California, 94401

  • Southeast Regional Research Group

    Savannah, Georgia, 31406

  • Arthritis Northwest PLLC

    Spokane, Washington, 99204

  • Suny Upstate Medical University

    Syracuse, New York, 13210

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

India30 sites

  • Institute of Kidney Diseases and Research (IKRD) and Institute of Transplantation Sciences (ITS)

    Ahmedabad, Asarwa, 380016

  • St. Johns Medical College and Hospital, Dept. of Nephrology

    Bangalore, Karnataka, 560 034

  • M.S. Ramaiah Memorial Hospital

    Bangalore, Karnataka, 560054

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160 012

  • Devaki Hospital Ltd., Dept. of Nephrology

    Chennai, 600 004

  • Madras Institute of Nephrology, Vijaya Health Center

    Chennai, 600 026

  • Spectra Apollo Research Foundation

    Chennai

  • Global Hospitals

    Hyderabaad, Andhra Pradesh, 500 004

  • Consultant and Head Department of Nephrology, Kamineni Hospitals

    Hyderabaad, L.B. Nagar, 500068

  • Medwin Hospital

    Hyderabaad, 500 001

  • Nizams Institute of Medical Sciences

    Hyderabaad, 500 082

  • Department of Nephrology, CARE Hospital, Banjara Hills

    Hyderabad, 500034

  • M.P. Shah Medical College & G.G. Hospital

    Jamnagar, Gujarat, 361001

  • PVS Memorial Hospital Ltd.

    Kochi, Kaloor, Kerala, 682017

  • Amrita Institute of Medical Sciences

    Kochi, Kerala, 682026

  • Apollo Gleneagles Hospital

    Kolkata, Kankurgachi, 700054

  • Armenian Church Trauma Center - Unit of Rabindranath Tagore International Institute of Cardiac Sciences

    Kolkata, 700-099

  • Sanjay Ghandi Post Graduate Institute of Medical Sciences

    Lucknow, 226014

  • Apollo Specialty Hospitals, Lake View Road, K.K., Nagar

    Madurai, Tamil Nadu, 625-020

  • BYL Nair Charitable Hospital & TN Medical College

    Mumbai, 400 008

  • Seth G.S. Medical College & KEM Hospital

    Mumbai, 400 012

  • P.D. Hinduja National Hospital and Research Center

    Mumbai, 400016

  • Department of Nephrology, JSS Hospital, Ramanuja Road

    Mysore, 570004

  • Department of Nephrology, All India Institute of Medical Sciences

    New Delhi, Ansari Nagar, 110029

  • Indraprastha Apollo Hospital

    New Delhi, 110044

  • Fortis Hospital, Dept. of Nephrology & Hypertension

    Noida, Uttar Pradesh

  • Sri Ramachandra Medical College & Research Institute (Deemed University)

    Porur, Chennai, 600 116

  • Jehangir Hospital, 32 Sassoon Road

    Pune, 411001

  • Medical College Trivandrum

    Trivandrum, 695011

  • King George Hospital

    Visakhapatnam, 530002

Other trials in India

Brazil14 sites

  • Santa Casa de Misericórdia de BeloHorizonte, Av. Francisco Sales, n. 1111 9 andar Ala D/ CCIH

    Belo Horizonte, Minas Gerais, CEP: 30150 221

  • Hospital e Maternidade Celso Pierro - PUCCampinas, Av. John Boyd Dunlop, s/n

    Campinas - Sāo Paulo, 13059-740

  • Hospital de Clinicas - Universidade Estadual de Campinas - UNICAMP, Rua Vital Brasil, 250 - 3º andar - Cidade Universitária Zeferin

    Campinas - SP, Cep: 13083-888

  • Athritis Clinica de Doenças Reumaticas, Av. Padre Anchieta, 1846 cj 1108

    Curitiba - PR, 80730-000

  • Hospital Geral de Goiania, GO Av Anhanguera 6479 Setor Oeste

    Goiania-GO, Goiás, CEP: 74 110 120

  • 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, 74605-020

  • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul-PUCRS

    Porto Alegre-RS, Av. Ipiranga, 6690-Conj. 220-Jardim Botanico, 90610-000

  • Hospital de Clinicas de Porto Alegre - HCPA

    Porto Alegre-RS, 90035-903

  • Hospital das Clínicas of Medicine School of University of São Paulo (USP) at Ribeirão Preto Rheumatology Department Avenida dos

    Ribeirão Preto, Cep: 14048-900

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro, Avenida 28 de Setembro, 77, 20.551-030

  • Hospital Santa Izabel, Praca Almeida Couto, 500 - Naxaré

    Salvador - BA, CEP: 40050 410

  • Hospital Hehopolis

    São Paulo, Avenida Almirante Delamare, 1534-Sacoman, 04230-000

  • Irmandade da Santa Casa de Misericórdia de Sāo Paulo Rua, Dr. Cesário Motta Junior, 112

    São Paulo, Cep: 01221-020

  • Rua Pedro de Toledo 1800 9 andar/ Ala central - Diretoria de Servico de Reumatologia

    Săo Paulo - SP, CEP: 04039 004

Other trials in Brazil

Taiwan12 sites

  • Buddhist Dalin Tzu Chi General Hospital, Vice Superintendent Room

    Dalin Town, Chia-Yi County, 622

  • Kaohsiung University Medical Hospital

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • Chang Gung Memorial Hospital

    Kaohsiung Hsien, 833

  • Chang Gung Memorial Hospital - Keelung

    Keelung, 204

  • Chung Shan Medical University Hospital

    Taichung, 402

  • China Medical University Hospital

    Taichung, 404

  • National Chang-Kung University Hospital

    Tainan

  • Taipei Veterans General Hospital - Immunology & Rheumatology Office

    Taipei, 112

  • Chang Gung Memorial Hospital - Taipei

    Taipei

  • Chang Gung Memorial Hospital

    Taoyuan

  • Chi Mei Foundation Hospital

    Yongkang District

Other trials in Taiwan

Mexico10 sites

  • Poliplaza Medica

    Chihuahua City, CP 32500

  • Instituto Nacional de Ciencias Medicas y Nutricion "Salvador Zubiran", Departmento de inmunologia y Reumatologia

    Delagacion Tlalpan, D.F., CP 14000

  • Colomos #2292, Col. Providencia

    Guadalajara, Jalisco, 44620

  • Centro de Estudios de Investigación Básica y Clínica S.C.

    Guadalajara, Jalisco, 44690

  • Hospital Aranda de la Parra

    León, Guanajuato, CP37000

  • Reumatologia

    Mexicali, CP 21100

  • Clínica de Diagnóstico y Tratamiento de las Enfermedades Reumáticas

    Mexico City, D.F., 06700

  • Hospital Star Medica

    Morelia, Michoacán, 58070

  • Hospital Privado San José de Ciudad Obregón, S.A. de C.V. Coahuila No. 263 Sur. Col. Centro. Ciudad Obregón

    Sonora, C.P. 85000

  • Blvd. Sanchez Taboada 9250-28 - Private Practice

    Tijuana, Estado de Baja California, cp22010

Other trials in Mexico

South Korea9 sites

  • Inha University Hospital

    Incheon, 400-711

  • Bundang Cha General Hospital, Pochon Cha University

    Kyonggi-do, 463-712

  • Pusan National University Hospital

    Pusan, 602-739

  • Ewha Woman's University College of Medicine, Mockdong Hospital

    Seoul, Yangcheon-Gu, 158-710

  • Seoul National University Hospital, Department of Internal Medicine

    Seoul, 110-744

  • The Hospital for Rheumatic Disease, Hanyang University Medical Center

    Seoul, 133-792

  • Kangnam St. Mary's Hospital, Catholic University of Korea

    Seoul, 137-040

  • St. Mary's Hospital, Catholic University of Korea

    Seoul, 150-713

  • Ajou University Medical Center, Ajou University School of Medicine

    Suwon, 442-721

Other trials in South Korea

Argentina8 sites

  • CIR Hospital Sirio Libanes. Campana 4658

    Buenos Aires, Ciudad Autonma de, C1419AHN

  • Organización Médica de la Investigación

    Buenos Aires, Uruguay 725 P.B., C1015ABO

  • Unidad de Alergia, Asma e Inmunología Clínica

    Buenos Aires, 1035

  • Centro de Investigaciones en Enfermedades Reumaticas (CIER)

    Buenos Aires, C1055AAF

  • Centro de Investigaciones Reumatologicas y Osteologicas

    Buenos Aires, C11117ABH

  • Investigación Clínica Polivalente

    La Plata, 1902

  • Instituto CAICI

    Rosario, Santa Fe Province, S2000PBJ

  • Centro de Investigaciones Reumatológicas

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Poland8 sites

  • Klinika Nefrologii, Transplantologii i Chorob Wewnetrznych - Akademickie Centrum Kliniczne - Szpital AMG

    Gdansk, 80-952

  • Klinika Chorob Wewnetrznych i Reumatologii - Gornoslaskie Centrum Medyczne, SPSK Nr 7 SL A M

    Katowice, 40-635

  • Oddzial Kiliniczny Nefrologii Hipertensjologii i Transplantologii Nerek SPZOZ, Uniwersytecki Szpital Kliniczny nr 1

    Lodz, 90153

  • Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

    Lublin, 20-954

  • Akademii Medycznej w Poznaniu, Zaklad Reumatologii i Immunologii Klinicznej

    Poznan, 61-626

  • Klinika Medycyny, Transplantacyjnej i Nefrologii in Warszawa, Nowogrodzka 59, At SPZOZ Szpital Kliniczny

    Warsaw, Dzieciatka Jezus-Centrum Leczenia Obrażeń, Lindleya 4, 02-005

  • Klinika Chorób Tkanki Łącznej

    Warsaw, 02-637

  • Klinika Nefrologii Dializoterapii I Chorob Wewnetrznych - Samodzielny Publiczny Centralny Szpital Kliniczny

    Warsaw, 02097

Other trials in Poland

Belarus6 sites

  • Gomel Regional Clinical Hospital

    Homyel, 246029

  • Minsk City Clinical Hospital # 2

    Minsk, 220020

  • Minsk City Clinical Hospital # 164

    Minsk, 220113

  • Minsk City Clinical Hospital # 9

    Minsk, 220116

  • Minsk Regional Clinical Hospital

    Minsk, 223040

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

Bulgaria6 sites

  • MHAT "Sveti Georgi", Clinic of Rheumatology

    Plovdiv, 15A "Vasil Aprilov" Blvd., 4002

  • NMTranspH "Tsar Boris Treti", Clinic of Internal Diseases

    Sofia, 104 "Maria Louisa" Blvd., 1233

  • MHAT "Sveti Ivan Rilski", Clinic of Rheumatology

    Sofia, 13 "Urvich" Street, 1612

  • Military Medical Academy, Clinic of Urology and Nephrology

    Sofia, 3, Georgi Sofiiski, Str., 1606

  • Clinic of Nephrology, MHAT "Alexandrovska" 1, Georgi Sofiiski, str.,

    Sofia, 1431

  • MHAT "Stara Zagora", Second Clinic of Internal Diseases

    Stara Zagora, 11 "Armeiska" Street, 6000

Other trials in Bulgaria

Ukraine6 sites

  • Donetsk Central Municipal Clinical Hospital #1

    Donetsk, 83114

  • Kyiv Central Municipal Clinical Hospital

    Kyiv, 01023

  • M.D. Strazhesko Institute of Cardiology AMS Ukraine

    Kyiv, 03680

  • Kyiv Regional Clinical Hospital

    Kyiv, 04107

  • Lviv Municipal Public Clinical Hospital

    Lviv, 79013

  • Vinnitsa Regional Clinical Hospital of MoH of Ukraine

    Vinnitsa, 21018

Other trials in Ukraine

Germany5 sites

  • Herz and Rheumazentrum Kerckhoff-klinik GmbH

    Bad Nauheim, Benekestrasse 2-8, 61231

  • Charité-Unversitätmedizin Berlin, CharitéCentrum Inn ere Medizin und Dermatologie

    Berlin, Chariteplatz 1, 10117

  • Georg August Universität Göttingen Universitätsklinikum, Zentrum Innere Medizin

    Göttingen, Robert-Kochstr. 40, 37075

  • Medizinische Klinik und Poliklinik IV des Universitätsklinikum Lepizig, Rheumatologie

    Leipzig, Liebigstrasse 22, 04103

  • Johannes Gutenberg-Universität I. Medizinische Klinik und Poliklinik,Langenbeckstr. 1

    Mainz, 55131

Other trials in Germany

Hungary5 sites

  • Szent Margit Hospital, Department of Nephrology

    Budapest, 1032

  • Diagnostic Units Hungary Kft.

    Budapest, 1036

  • Szent László Kórház, VI. Fertőző Belosztály

    Budapest, 1097

  • Debrecen Medical University

    Debrecen, 4004

  • Petz Aladar Megyei Oktato Korhaz, Immunnephrologia es Hypertonia Osztaly

    Győr, 9024

Other trials in Hungary

Lebanon5 sites

  • Albert Haykel Hospital

    Haykaliyeh-Tripoli

  • Nabatieh Governmental Hospital

    Nabatieh

  • Rayak Hospital

    Riyaq, Bekaa Valley

  • Hammoud Hospital University Medical Center

    Saida

  • Labib Medical Center

    Saida

Other trials in Lebanon

Portugal5 sites

  • Centro Hospitalar de Lisboa Norte, EPE, Hospital de Santa Maria - Reumatologia

    Lisbon, Av. Prof. Egas Moniz, 1649-035

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Egas Moniz, Unidade de Reumatologia

    Lisbon, Rua Da Junqueira, 126, 1300

  • Centro Hospitalar do Porto, EPE - Hospital de Santo Antonio, Departamento de Medicina - Unidade de Imunologia Clinica

    Porto, Largo Prof. Abel Salazar, 4099-001

  • Hospital de Sāo Jeāo, Servico de Nefrologia

    Porto, 4200-319

  • Centro Hospitalar de Vila Nova de Gaia

    Vila Nova de Gaia, Rua Conceicao Fernandes, 4434-502

Other trials in Portugal

Philippines4 sites

  • Chung Hua Hospital

    Cebu, 6000

  • Davao Doctors Hospital

    Davao City, 8000

  • Philippine General Hospital

    Manila, 1000

  • Joint and Bone Center, University of Santo Tomas Hospital

    Manila

Other trials in Philippines

Romania4 sites

  • "Sf. Maria" Clinical Hospital

    Bucharest, 011172

  • "Ion Stoia" Center of Rheumatic Diseases

    Bucharest, 020983

  • Emergency Clinical County Hospital Cluj

    Cluj-Napoca, 400006

  • Rehabilitation Clinical Hospital

    Iași, 700661

Other trials in Romania

Serbia4 sites

  • Institute of Nephrology and Urology Clinical Centre of Serbia

    Belgrade, 11000

  • Institute of Rheumatology

    Belgrade, 11000

  • University Medical Centre "Zvezdara", Clinical Department for Renal Diseases, Dimitrija Tucovica 161

    Belgrade, 11000

  • Institute of Prevention, Treatment and Rehabilitation of Rheumatoid and Cardiovascular Patients "Niska Banja"

    Niška Banja, 18205

Other trials in Serbia

Australia3 sites

  • Rheumatology Clinic

    Cairns, QLD 4870

  • Dept Medicine, Level 3 Wallace Freeborn Building, Royal North Shore Hospital, Pacific Highway

    St Leonards, NSW 2065

  • Vincents Hospital Daly Building, 41 Victoria Parade Fitzroy

    Victoria, 3065 702

Other trials in Australia

Czechia3 sites

  • Fakultni nemocnice Plzen, Oddeleni klinické farmakologie

    Pilsen, Edvarda Benese, 13305 99

  • VFN Prahal Lékarská fakulta, Klinika detského a dorostového lékarstvi,

    Prague, Ke Karlovu, 09 Praha 2,, 2121

  • Revmatologický ústav

    Prague, 128 50

Other trials in Czechia

Indonesia3 sites

  • RS Hasan Sadikin

    Bandung, Jl. Pasir Kaliki No. 190, Jawa Barat, 40161

  • RS Kramat 128

    Jakarta, Jl. Kramat Raya, Pusat, 128

  • Dept. of Internal Medicine, Saiful Anwar General Hospital

    Malang, Jl. J.A. Suprapto No. 2, 65111

Other trials in Indonesia

Italy3 sites

  • Arcispedale S. Anna, Divisione di Reumatologia

    Ferrara, Corso Giovecca 203, 44100

  • Azienda Ospedaliera Cattedra di Reumatologia

    Padova, Via Giustiniani, 2, 35128

  • Universita di Pisa, Dipartimento di Medicina Interna

    Pisa, Via Roma 67, 56126

Other trials in Italy

Malaysia3 sites

  • Department of Medicine, Hospital Pulau Pinang,

    Pulau Pinang, Jalan Residensi, 10990

  • CAPD Unit, Queen Elizabeth Hospital,

    Sabak Bernam, Kota Kinabalu, 88586

  • Department of Medicine, Sarawak General Hospital, Jalan Tun Ahmad Zaidi Adruce,

    Sarawak, Kuching, 93586

Other trials in Malaysia

Spain3 sites

  • Hospital Clinic i Provincial de Barcelona, Centre Ciutat, Facultat de Medicina, Servicio de Enfermedades Autoinmunes

    Barcelona, Calle Villarroel, 170, 08036

  • Hospital Universitari Vall d'Hebron, Servicia Medicina Interna, Edificio General, 3a Planta

    Barcelona, Paseo Valle de Hebron 119-129, 08035

  • Hospital Universitario La Paz, Servico de Medicine Interne Planta 10

    Madrid, Paseo de La Castellana 261, 28046

Other trials in Spain

Thailand3 sites

  • Department of Medicine, King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Ramathibodi Hospital - Division of Allergy, Immunology & Rheumatology, Dept. of Medicine

    Bangkok, 10400

  • Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine

    Bangkok, 10400

Other trials in Thailand

Hong Kong2 sites

  • Hong Kong University, Queen Mary Hospital

    Hong Kong

  • The Chinese University of Hong Kong, Prince of Wales Hospital

    Hong Kong

Other trials in Hong Kong

Slovakia2 sites

  • Reumatologicka ambulancia Fakultna nemocnica F D Roosevelta

    Banska, Bystrica, 97517

  • Reumatologicka ambulancia Fakultna nemocnica s poliklinikou Milosrdni bratia spol s r o

    Bratislava, 81465

Other trials in Slovakia

Georgia1 site

  • Academic VL Tsitlanadze Scientific - Practical Center of Rheumatology

    Tbilisi, 0102

Other trials in Georgia

Puerto Rico1 site

  • RCMI Clinical Research Center, 1st Floor University Hospital Medical Center

    San Juan, 00935

Other trials in Puerto Rico

Sri Lanka1 site

  • University Lupus Clinic of the Department of Clinical Medicine, Faculty of Medicine, University of Colombo, P.O. Box 271, No 25,

    Colombo, Kynsey Road, 08

Other trials in Sri Lanka

About this study

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

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.

Being tested
abetimus sodium (LJP 394) and/or placebo solution, abetimus sodium (LJP 394), Phosphate-buffered saline
Keywords
Lupus, Nephritis, Kidney, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis, Nephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abetimus sodium (LJP 394) and/or placebo solutionDrug

    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)Drug

    900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.

  • Phosphate-buffered salineDrug

    Also called Placebo, normal 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

Study groups in NCT00089804
Study groupRoleWhat they receive
1Active comparator300 mg (three 2 mL vials of abetimus sodium plus six 2 mL vials of normal saline) administered i.v (in the vien) weekly
Receives: Drug: abetimus sodium (LJP 394) and/or placebo solution
2Active comparator900 mg (nine 2 mL vials of abetimus sodium) administered i.v. (in the vein) weekly
Receives: Drug: abetimus sodium (LJP 394)
3Placebo comparatorA volume of 18 mL (Nine 2 mL vials) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly
Receives: Drug: Phosphate-buffered saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Time to event (12 months fixed treatment duration)

Secondary outcomes (1)

  1. 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.

    Measured: 12 month fixed treatment duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2004 (estimated)
  2. Study startOct 2004
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Why it stopped: Interim efficacy analysis indicated it would be futile to continue study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
943 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089804
Sponsor's protocol ID
LJP 394-90-14
Acronym
ASPEN
Status last verified
Mar 2009
First submitted
13 Aug 2004
Last updated
1 Apr 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing abetimus sodium (LJP 394) and Phosphate-buffered saline in people with Lupus Erythematosus, Systemic and Lupus Nephritis, run by La Jolla Pharmaceutical Company at 201 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, India, Brazil, Taiwan, Mexico and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Interim efficacy analysis indicated it would be futile to continue study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2009.

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