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

Lupus Nephritis Clinical Trial

— ASPEN  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00089804
• Other study ID #: LJP 394-90-14
• Status: Terminated
• Phase: Phase 3
• First received: August 13, 2004
• Last updated: March 30, 2009
• Start date: October 2004
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: La Jolla Pharmaceutical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 943
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis

Intervention

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
• abetimus sodium (LJP 394)
900 mg (50 mg/mL) abetimus sodium (nine 2 mL vials) administered i.v. (in the vien) weekly for 52 weeks.
• Phosphate-buffered saline
A volume of 18 mL (nine 2 mL vials of normal saline) of identically appearing placebo (phosphate-buffered saline) administered i.v. (in the vien) weekly for 52 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
La Jolla Pharmaceutical Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belarus,  Brazil,  Bulgaria,  Czech Republic,  Georgia,  Germany,  Hong Kong,  Hungary,  India,  Indonesia,  Italy,  Korea, Republic of,  Lebanon,  Malaysia,  Mexico,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Serbia,  Slovakia,  Spain,  Sri Lanka,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	Yes

External Links

•   Sponsor's website