Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
NCT ID: NCT00423098
Last Updated: 2011-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
81 participants
INTERVENTIONAL
2007-02-28
2009-11-30
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
NONE
Study Groups
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Standard dose
Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
Low dose
Mycophenolate sodium was administered in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of Prednisone was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
Interventions
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Mycophenolate sodium
Mycophenolate sodium as administered orally for 2 weeks at 1440mg daily and then increased to 2160mg daily for 22 weeks.
Prednisone
Oral prednisone or prednisone equivalent was started on Day 4 and subsequently tapered every 2 weeks according to the patient's weight.
Methylprednisolone
All patients received bolus therapy with 0.5 g of intravenous Methylprednisolone per day for 3 consecutive days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged ≥18 years,
* Proliferative lupus nephritis classified as ISN/RPS class III or IV
* Renal biopsy within the last 24-month preceding the study entry
* Proteinuria defined as \>0.5 gram urine protein per gram urine creatinine at screening and baseline
* Clinical activity defined by one or more of the following changes in renal function: Serum creatinine \>1.0 mg/dl (88.4 μmol/l)
* Microscopic hematuria defined as \>5 red cells per high power field
* Presence of cellular casts
Exclusion Criteria
* Patients having received an intravenous (i.v.) corticosteroid bolus during the last 3 months,
* Patients having received oral or i.v. cyclophosphamide during the last 3 month
* Patients having received mycophenolate mofetil (MMF) within the preceding 3 months
* Use of any antibody therapy within the past 6 months
* Pregnant or nursing (lactating) women or women of child-bearing potential who are planning to become pregnant, or are not willing to use effective means of contraception throughout the study and during one month after the end of the study.
* Use of other investigational drugs within 1 month of enrollment (except for antibodies: within 6 months of enrollment
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures,
* History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis
Bogotá, , Colombia
Novartis
Créteil, , France
Novartis
Nantes, , France
Novartis Investigative Site
Paris, , France
Novartis
Berlin, , Germany
Novartis
Tübingen, , Germany
Novartis
Athens, , Greece
Novartis
Budapest, , Hungary
Novartis
Debrecen, , Hungary
Novartis
Brescia, , Italy
Novartis
Ferrara, , Italy
Novartis
Milan, , Italy
Novartis
Padua, , Italy
Novartis
Barcelona, , Spain
Novartis
Madrid, , Spain
Novartis
Taichung, , Taiwan
Novartis
Cambridge, , United Kingdom
Countries
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Other Identifiers
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CERL080A2420
Identifier Type: -
Identifier Source: org_study_id
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