Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 7
- 主要终点
- Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Kidney biopsy within 1 year, with histological diagnosis of LN (class III/IV/V)
- •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.
- •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.
排除标准
- •Previous or planned kidney transplant.
- •Were receiving continuous dialysis or GFR < 30 mL/min/1.73 m2 within 3 months prior to the start of study.
- •Patients with active serious digestive system disease, including infrequent cases of gastrointestinal tract ulceration with hemorrhage or perforation.
- •Patients with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.
研究组 & 干预措施
Myfortic
Oral administration
干预措施: Myfortic (Drug)
结局指标
主要结局
Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients
时间窗: 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.
次要结局
- Reasons for study drug discontinuation(12 months)
- Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)(month 6, month 12)
- Proportion of patients achieving inactive urinary sediment(month 6, month 12)
- Proportion of patients with a complete response(month 6, month 12)
- Proportion of patients with a partial response(month 6, month 12)