Clinical trial NCT00423098: Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
Official title: A Randomized, Multicenter, Open-label, 6-month Study to Explore the Efficacy and Safety of Enteric-coated Mycophenolate Sodium in Combination With Two Corticosteroid Regimens for the Treatment of Lupus Nephritis Flare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis
enteric-coated mycophenolate sodium
EC-MPS
Myfortic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-17
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate the efficacy and safety of enteric-coated mycophenolate sodium in combination with two different corticosteroid (CS) regimes for the induction of remission of a lupus nephritis flare. Patients will be randomly allocated to standard CS regimen (group I) or to a reduced dose CS regimen (group II)


Eligibility criteria: Inclusion criteria

* Male or female patients with systemic lupus erythematosus (SLE)(at least 4 classification 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 with calculated creatinine clearance \<30 ml/min (using the Cockcroft-Gault formula)
* 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Patients With Complete Remission
timeFrame: 24 Weeks
Secondary outcomes:
measure: Number of Patients With Complete Remission
timeFrame: 12 Weeks
measure: Number of Patients With Partial Remission
timeFrame: Baseline to 12 and 24 weeks
measure: Cumulative Dose of Prednisone Equivalent Corticosteroids (CS)
timeFrame: 12 Weeks and 24 Weeks
measure: Number of Patients With Moderate to Severe Flares
timeFrame: 12 and 24 weeks
measure: Duration of Exposure to Study Medication
timeFrame: 24 weeks
measure: Number of Patients With Adverse Events and Infections
timeFrame: 24 weeks
measure: Number of Patients With Treatment Failure
timeFrame: 12 Weeks and 24 Weeks
measure: Change From Baseline in Overall Disease Activity With Systematic Lupus Erythematosus Disease Activity Index (SLEDAI)
timeFrame: From Baseline to week 4, week 12 and week 24
measure: Change From Baseline in Overall Disease Activity With British Isles Lupus Assessment Group (BILAG)
timeFrame: From Baseline to week 4, week 12 and week 24
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Novartis
city: Creteil
country: France
facility: Novartis
city: Nantes
country: France
facility: Novartis
city: Paris
country: France
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis
city: Tubingen
country: Germany
facility: Novartis
city: Athens
country: Greece
facility: Novartis
city: Budapest
country: Hungary
facility: Novartis
city: Debrecen
country: Hungary
facility: Novartis
city: Brescia
country: Italy
facility: Novartis
city: Ferrara
country: Italy
facility: Novartis
city: Milano
country: Italy
facility: Novartis
city: Padova
country: Italy
facility: Novartis
city: Barcelona
country: Spain
facility: Novartis
city: Madrid
country: Spain
facility: Novartis
city: Taichung
country: Taiwan
facility: Novartis
city: Cambridge
country: United Kingdom
facility: Novartis
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: