Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
NCT ID: NCT01714817
Last Updated: 2021-02-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
695 participants
INTERVENTIONAL
2013-01-22
2018-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-188667 + Mycophenolate mofetil + Prednisone
BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
BMS-188667
Mycophenolate mofetil
Prednisone
Placebo + Mycophenolate mofetil + Prednisone
Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
Mycophenolate mofetil
Prednisone
Placebo matching with BMS-188667
Interventions
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BMS-188667
Mycophenolate mofetil
Prednisone
Placebo matching with BMS-188667
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)
* Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
* Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)
* There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:
* Worsening of lupus nephritis OR
* UPCR ≥ 3 at Screening OR
* Active urine sediment OR
* Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis
* Signed Written Informed Consent
* Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment
Exclusion Criteria
* Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
* Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
* Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University Of Alabama At Birmingham (Uab)
Birmingham, Alabama, United States
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
Long Beach, California, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, United States
University Of Connecticut Health Center
Farmington, Connecticut, United States
University Of Miami Miller School Of Medicine
Miami, Florida, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Emory University.
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Tulane University School Of Medicine
New Orleans, Louisiana, United States
Brigham & Women'S Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Local Institution
Camden, New Jersey, United States
Suny Downstate Medical Center
Brooklyn, New York, United States
Northshore Lij Health System
Great Neck, New York, United States
The Feinstein Institute For Medical Research
Manhasset, New York, United States
Hospital For Special Surgery
New York, New York, United States
Local Institution
New York, New York, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States
Shanahan Rheum & Immunotherapy, PLLC
Raleigh, North Carolina, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio, United States
Rheumatology Consultants Pllc
Knoxville, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University Of Utah Hospital
Salt Lake City, Utah, United States
Local Institution
Charlottesville, Virginia, United States
Organizacion Medica De Investigacion S.A. (Omi)
Capital Federal, Buenos Aires, Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina
Local Institution
Buenos Aires, , Argentina
Hospital Privado-Centro Medico De Cordoba S.A.
Córdoba, , Argentina
Local Institution
Adelaide, South Australia, Australia
Local Institution
Parkville, Victoria, Australia
Local Institution
Perth, Western Australia, Australia
Local Institution
Savaldor, Estado de Bahia, Brazil
Local Institution
Goiânia, Goiás, Brazil
Local Institution
Belo Horizonte, Minas Gerais, Brazil
Local Institution
Juiz de Fora, Minas Gerais, Brazil
Local Institution
Uberlândia, Minas Gerais, Brazil
Local Institution
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution
São Paulo, , Brazil
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Mississauga, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
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Viña del Mar, Región de Valparaíso, Chile
Local Institution
Independencia, Santiago Metropolitan, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Santiago, Santiago Metropolitan, Chile
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
Local Institution
Haikou, Hainan, China
Local Institution
Wuhan, Hebei, China
Local Institution
Harbin, Heilongjiang, China
Local Institution
Zhengzhou, Henan, China
Local Institution
Wuxi, Jiangsu, China
Local Institution
Nanchang, Jiangxi, China
Local Institution
Xi'an, Shan1xi, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
Local Institution
Beijing, , China
Local Institution
Chongqing, , China
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Guangzhou, , China
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Nanchang, , China
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Nanning, , China
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Shanghai, , China
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Shanghai, , China
Local Institution
Shanghai, , China
Local Institution
Xi'an, , China
Riesgo De Fractura S.A. Cayre Ips
Bogota, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, Santander Department, Colombia
Clinica De La Costa
Barranquilla, , Colombia
Circaribe S.A.S
Barranquilla, , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Local Institution
Prague, , Czechia
Local Institution
Hong Kong, , Hong Kong
Local Institution
Secunderabad, Andhra Pradesh, India
Local Institution
Ahmedabad, Gujarat, India
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Gurgaon, , India
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Hyderabad, , India
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Lucknow, , India
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New Delhi, , India
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Haifa, , Israel
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Haifa, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Brescia, , Italy
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Milan, , Italy
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Padua, , Italy
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Reggio Emilia, , Italy
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Torino, , Italy
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Nagakute-shi, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Chiba, Chiba, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kitakyushu-shi, Fukuoka, Japan
Local Institution
Maebashi, Gunma, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kanazawa, Ishikawa-ken, Japan
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Yokohama, Kanagawa, Japan
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Sendai, Miyagi, Japan
Local Institution
Nagasaki, Nagasaki, Japan
Local Institution
Niigata, Niigata, Japan
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Okayama, Okayama-ken, Japan
Local Institution
Iruma-gun, Saitama, Japan
Local Institution
Shimotsuke-shi, Tochigi, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Local Institution
Fuchū, Tokyo, Japan
Local Institution
Ōta-ku, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Kita-gun, , Japan
Local Institution
Osaka, , Japan
Local Institution
Mexico City, Distrito Fededral, Mexico
Centro De Est D Inv. Basica Y Clinica
Guadalajara, Jalisco, Mexico
Local Institution
Guadalajara, Jalisco, Jalisco, Mexico
Hospital De Jesus
Mexico City, Mexico City, Mexico
Hospital General De Mexico O.D.
Mexico City, Mexico City, Mexico
Centro Medico De Las Americas
Mérida, Yucatán, Mexico
Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
Distrito Federal, , Mexico
Centro Potosino de Inv Clinica
San Luis Potosí City, , Mexico
Hosp Central I.Morones Prieto
San Luis Potosí City, , Mexico
Hospital Nacional Guillermo Almenara Irigoyen
Lima, , Peru
Hospital Nacional Cayetano Heredia
Lima, , Peru
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, , Peru
Local Institution
San Juan, , Puerto Rico
Local Institution
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution
Bucharest, , Romania
Local Institution
Cluj-Napoca, , Romania
Local Institution
Iași, , Romania
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Ufa, , Russia
Local Institution
Daegu, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Madrid, , Spain
Local Institution
Madrid, , Spain
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Kaohsiung City, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taichung, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Local Institution
Antalya, , Turkey (Türkiye)
Local Institution
Edirne, , Turkey (Türkiye)
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2012-000714-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM101-291
Identifier Type: -
Identifier Source: org_study_id
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