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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myfortic | Oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myfortic | Drug | There is no treatment allocation. Patients administered Myfortic by prescription that had started before inclusion of the patient into the study were enrolled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons for study drug discontinuation | To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc. | 12 months |
| Proportion of patients with a complete response |
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Inclusion Criteria:
Aged ≥ 20 years and ≤ 75 years at screening.
Patients with written informed consent form.
Male or female diagnosed with SLE.
Confirmed diagnosis of LN by physician. Diagnosis of LN was defined as:
Patients with LN who received EC-MPS for the first time. The patients who switched from other treatment and treatment naive patients (did not receive any treatment before) could be included in this study.
Women of childbearing potential must have used effective contraception before beginning EC MPS therapy, during therapy, and for six weeks after their last dose of EC MPS.
Exclusion Criteria:
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The study population will consist of male and female patients diagnosed with LN between 20 and 75 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kaohsiung City | 83301 | Taiwan | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
Patients were reported to have a complete response if their proteinuria is < 0.5 g/24 hours; or UPCR≤ 0.5.
| 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:
| 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) | month 6, month 12 |
| Proportion of patients achieving inactive urinary sediment | The proportion of patients achieving inactive urinary sediment (no cellular casts) | month 6, month 12 |
| Keelung |
| 20401 |
| Taiwan |
| Novartis Investigative Site | Taichung | 407219 | Taiwan |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 105 | Taiwan |
| Novartis Investigative Site | Taoyuan | 33305 | Taiwan |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |