Lupus Nephritis
Conditions
Keywords
Lupus Nephritis, LN, Myfortic, Mycophenolate sodium
Brief summary
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).
Detailed description
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.
Interventions
DRUGMyfortic
There is no treatment allocation. Patients administered Myfortic by prescription that had started before inclusion of the patient into the study were enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 20 years and ≤ 75 years at screening. 2. Patients with written informed consent form. 3. Male or female diagnosed with SLE. 4. Confirmed diagnosis of LN by physician. Diagnosis of LN was defined as: 1. Kidney biopsy within 1 year, with histological diagnosis of LN (class III/IV/V) 2. Laboratory evidence of active nephritis: spot UPCR\>0.5, and/or proteinuria \> 0.5 g/24 hours, and/or greater than 3+ by dipstick, and/or cellular casts. 5. 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. 6. 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
1. Previous or planned kidney transplant. 2. Were receiving continuous dialysis or GFR \< 30 mL/min/1.73 m2 within 3 months prior to the start of study. 3. Patients with active serious digestive system disease, including infrequent cases of gastrointestinal tract ulceration with hemorrhage or perforation. 4. Patients with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons for study drug discontinuation | 12 months | To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc. |
| Proportion of patients with a complete response | month 6, month 12 | Patients were reported to have a complete response if their proteinuria is \< 0.5 g/24 hours; or UPCR≤ 0.5. |
| Proportion of patients with a partial response | month 6, month 12 | 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). |
| Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR) | month 6, month 12 | 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) |
| Proportion of patients achieving inactive urinary sediment | month 6, month 12 | The proportion of patients achieving inactive urinary sediment (no cellular casts) |
Countries
Taiwan
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed