A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
NCT ID: NCT00377637
Last Updated: 2011-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2005-07-31
2010-03-31
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
NONE
Study Groups
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Induction Phase: Mycophenolate mofetil
Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24 weeks of the Induction Phase.
Mycophenolate mofetil (MMF)
Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
Corticosteroid
Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Induction Phase: Cyclophosphamide
Participants received monthly infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
Cyclophosphamide
Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.
Dosing was started at 0.75 g/m\^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m\^2. The target dose was 1.0 g/m\^2, but doses were titrated by 0.25 g/m\^2 increments to maintain nadir leukocyte count between 2500-4000/mm\^3.
Corticosteroid
Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Maintenance Phase: Mycophenolate mofetil
Participants received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
Mycophenolate mofetil (MMF)
Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
Placebo to Azathioprine
Placebo capsules matching Azathioprine taken orally once a day.
Corticosteroid
Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Maintenance Phase: Azathioprine
Participants received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
Azathioprine
2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
Placebo to Mycophenolate mofetil
Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
Corticosteroid
Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Interventions
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Mycophenolate mofetil (MMF)
Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.
Cyclophosphamide
Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.
Dosing was started at 0.75 g/m\^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m\^2. The target dose was 1.0 g/m\^2, but doses were titrated by 0.25 g/m\^2 increments to maintain nadir leukocyte count between 2500-4000/mm\^3.
Azathioprine
2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.
Placebo to Azathioprine
Placebo capsules matching Azathioprine taken orally once a day.
Placebo to Mycophenolate mofetil
Placebo tablets matching Mycophenolate mofetil taken orally twice daily.
Corticosteroid
Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosis of systemic lupus erythematosus;
* kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis;
* laboratory evidence of active nephritis.
Exclusion Criteria
* previous or planned kidney transplant;
* other clinically significant active medical conditions.
12 Years
75 Years
ALL
No
Sponsors
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Aspreva Pharmaceuticals
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Huntsville, Alabama, United States
La Jolla, California, United States
Los Angeles, California, United States
San Francisco, California, United States
San Leandro, California, United States
Torrance, California, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Columbia, Missouri, United States
Brooklyn, New York, United States
Lake Success, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
San Isidro, , Argentina
San Miguel de Tucumán, , Argentina
Adelaide, , Australia
Camperdown, , Australia
Melbourne, , Australia
Parkville, , Australia
Woodville, , Australia
Brussels, , Belgium
Leuven, , Belgium
Liège, , Belgium
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Beijing, , China
Guangdong, , China
Guangzhou, , China
Jiangsu, , China
Shanghai, , China
Brno, , Czechia
Prague, , Czechia
Lille, , France
Lyon, , France
Nantes, , France
Paris, , France
Paris, , France
Toulouse, , France
Aachen, , Germany
Bad Bramstedt, , Germany
Berlin, , Germany
Berlin, , Germany
Dresden, , Germany
Düsseldorf, , Germany
Erlangen, , Germany
Hanover, , Germany
Leipzig, , Germany
München, , Germany
München, , Germany
Münster, , Germany
Athens, , Greece
Athens, , Greece
Heraklion, , Greece
Debrecen, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Brescia, , Italy
Milan, , Italy
Padua, , Italy
Pisa, , Italy
Udine, , Italy
Mexico City, , Mexico
Mérida, , Mexico
San Luis Potosí City, , Mexico
Lisbon, , Portugal
Porto, , Portugal
Alicante, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Santander, , Spain
Seville, , Spain
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Sheffield, , United Kingdom
Southampton, , United Kingdom
Countries
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References
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Sundel R, Solomons N, Lisk L; Aspreva Lupus Management Study (ALMS) Group. Efficacy of mycophenolate mofetil in adolescent patients with lupus nephritis: evidence from a two-phase, prospective randomized trial. Lupus. 2012 Nov;21(13):1433-43. doi: 10.1177/0961203312458466. Epub 2012 Aug 24.
Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D, Eitner F, Appel GB, Contreras G, Lisk L, Solomons N; ALMS Group. Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. N Engl J Med. 2011 Nov 17;365(20):1886-95. doi: 10.1056/NEJMoa1014460.
Dall'Era M, Stone D, Levesque V, Cisternas M, Wofsy D. Identification of biomarkers that predict response to treatment of lupus nephritis with mycophenolate mofetil or pulse cyclophosphamide. Arthritis Care Res (Hoboken). 2011 Mar;63(3):351-7. doi: 10.1002/acr.20397. Epub 2010 Nov 15.
Ginzler EM, Wofsy D, Isenberg D, Gordon C, Lisk L, Dooley MA; ALMS Group. Nonrenal disease activity following mycophenolate mofetil or intravenous cyclophosphamide as induction treatment for lupus nephritis: findings in a multicenter, prospective, randomized, open-label, parallel-group clinical trial. Arthritis Rheum. 2010 Jan;62(1):211-21. doi: 10.1002/art.25052.
Isenberg D, Appel GB, Contreras G, Dooley MA, Ginzler EM, Jayne D, Sanchez-Guerrero J, Wofsy D, Yu X, Solomons N. Influence of race/ethnicity on response to lupus nephritis treatment: the ALMS study. Rheumatology (Oxford). 2010 Jan;49(1):128-40. doi: 10.1093/rheumatology/kep346. Epub 2009 Nov 20.
Other Identifiers
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WX17801
Identifier Type: -
Identifier Source: org_study_id
NCT00121082
Identifier Type: -
Identifier Source: nct_alias