An observational study in Lupus Nephritis, sponsored by Novartis Pharmaceuticals. Completed at 6 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Novartis Pharmaceuticals · Observational
This was an open-label, prospective, single-arm, observational study in patients with Lupus nephritis (LN) who newly (i.e.,for the first time) received treatment of Enteric-coated Mycophenolate Sodium (EC-MPS).
This was an observational study. Patients were treated and followed according to routine medical practice in terms of visit frequency and type of assessment performed. Only endpoint related data were collected as part of the study. Patient demographic information, disease characteristics, treatments and laboratory data was collected retrospectively.
331 studies on the registry are indexed under Lupus Nephritis; 131 are open to participants now.
This study's enrollment of 69 is below the median of 99 across 80 observational studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of male and female patients diagnosed with LN between 20 and 75 years of age.
Confirmed diagnosis of LN by physician. Diagnosis of LN was defined as:
Exclusion Criteria:
Oral administration
Drug: Myfortic
There is no treatment allocation. Patients administered Myfortic by prescription that had started before inclusion of the patient into the study were enrolled.
Also known as: Mycophenolate sodium
Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients
The primary endpoint is the safety of EC-MPS in LN patients, which was assessed via the adverse events (AEs), serious adverse events (SAEs) and deaths.
Time frame: 12 months
Reasons for study drug discontinuation
To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc.
Time frame: 12 months
Proportion of patients with a complete response
Patients were reported to have a complete response if their proteinuria is \< 0.5 g/24 hours; or UPCR≤ 0.5.
Time frame: month 6, month 12
Proportion of patients with a partial response
Patients were reported to have a partial response if they experience any one criteria as follows: * At least 50% decrease from baseline in proteinuria. Note: patients with a baseline proteinuria of \>3.5 g/24 hours, must have a proteinuria \< 3 g/24 hours; * Red blood cells per high power field (RBCs/HPF) ≤50% above baseline and no RBC casts; * At least 50% decrease in UPCR or to \<1.0 (if 1.0 ≤ baseline ≤3.0) or to ≤3.0 (if baseline was \>3.0).
Time frame: month 6, month 12
Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)
The proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR). (eGFR within the normal range, or no less than 85% of baseline)
Time frame: month 6, month 12
Proportion of patients achieving inactive urinary sediment
The proportion of patients achieving inactive urinary sediment (no cellular casts)
Time frame: month 6, month 12
Plan to share: No
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals