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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2005-003070-19-HU |
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Date of registration:
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03/02/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupus
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Scientific title:
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A randomized, multicenter, parallel-group, open-label study to assess the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS, myfortic®) versus continuation of previous therapy in patients with proliferative lupus nephritis on standard maintenance therapy - Mylupus |
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Date of first enrolment:
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25/04/2006 |
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Target sample size:
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140 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003070-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other: yes
Other specify the comparator: comparator arm is standard maintenance therapy according to local practice
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Hungary
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Key inclusion & exclusion criteria
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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:
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)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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lupus nephritis ( as part of the disease "Systemic Lupus Erythematosus")
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Intervention(s)
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Trade Name: Myfortic
Product Name: Myfortic
Product Code: ERL080A
Pharmaceutical Form: Tablet
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Primary Outcome(s)
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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.
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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
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Primary end point(s): Primary efficacy variable will be the daily dose of corticosteroids over 24 months, measured in mg/kg/day
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Secondary ID(s)
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ERL080A2410
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 05/04/2006
Contact:
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