lupus nephritis ( as part of the disease "Systemic Lupus Erythematosus")
Conditions
Interventions
Trade Name: Myfortic
Product Name: Myfortic
Product Code: ERL080A
Pharmaceutical Form: Tablet
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following inclusion criteria must be present at Screening visit 1, prior to randomization 1. Males or females, aged 18 years and over 2. Patients meeting the diagnostic criteria for SLE (Appendix 3), according to ACR guidelines (including screening for anti-dsDNA (antibody to native DNA in abnormal titer) 3. Histological diagnosis of proliferative lupus nephritis (WHO III,IV, or V+III or V + IV). This can be a historical classification, from any timepoint before inclusion into the study 4. Patients treated with standard maintenance therapy (e.g. prednisone 0.5mg/kg or less/day, azathioprine, or cyclophosphamide). Patients who received therapy with mycophenolic acids (MPAs) greater than 12 months prior to inclusion in the study, and who did not discontinue due to MMF side effects, can also be included 5. Patients with persistent proteinuria (>0.5g/day) 6. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Creatinine clearance of < 20ml/min 2. Patients with any clinically significant infection 3. Patients with known hypersensitivity to myfortic® or to drugs with similar chemical structures 4. Patients who have received therapy with mycophenolic acids (MPAs) within 12 months prior to inclusion in the study 5. Patients who have received an investigational drug within four weeks prior to study entry 6. Patients with a 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 7. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. 8. Patients with active SLE CNS manifestations or a past history of SLE CNS complications ( eg psychosis, grandmal seizures)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess, in patients with lupus nephritis, the steroid use of a regimen with myfortic® versus continuation of previous therapy, by assessing the daily steroid doses while maintaining efficacy.;Secondary Objective: The secondary objective is to determine the efficacy and safety of an MPA based, steroid free regimen. This will be evaluated by: • Impact on renal function as assessed by serum creatinine and creatinine clearance • Impact on proteinuria (protein: creatinine ratio) • Maintenance of remission (renal and extra-renal flares) • Incidence of infection • Incidence of adverse events • Evaluation of BILAG (British Isles Lupus Assessment Group) and Systematic Lupus Erythematosus Disease Activity Index (SLEDAI) activity indices Evaluation of organ damage, utilizing the Systemic Lupus Erythematosus International Collaborating Clinics/ American College of Rheumatology (SLICC/ACR) Damage Index Assessment of HRQL using MOS SF-36 ;Primary end point(s): Primary efficacy variable will be the daily dose of corticosteroids over 24 months, measured in mg/kg/day | — |
Countries
Hungary
Outcome results
None listed