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

Phase 1

Active, not recruiting

• Conditions: lupus nephritis ( as part of the disease Systemic Lupus Erythematosus)

• Registration Number: EUCTR2005-003070-19-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-03
• Study Completion: 2007-03-28
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 0

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified