A Prospective Observational Registry of Patients Treated With LUPKYNIS® (Voclosporin) in the US
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Effectiveness of LUPKYNIS
研究概览
简要总结
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in adult patients with lupus nephritis (LN) in the United States (US).
详细描述
This registry is an observational study designed to assess the utilization and effectiveness of LUPKYNIS in patients with lupus nephritis (LN) in the United States (US). This registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on LUPKYNIS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lupus nephritis (LN) confirmed by biopsy
- •Initiating or have initiated treatment with commercial LUPKYNIS as per US approved Prescribing Information (PI)
- •Written informed consent
排除标准
- •Off-label use (Use of LUPKYNIS outside of the FDA-approved US Prescribing Information)
研究组 & 干预措施
Lupkynis Treatment Group
干预措施: LUPKYNIS (Drug)
结局指标
主要结局
Effectiveness of LUPKYNIS
时间窗: 12 months (1 year) to 60 months (5 years)
The proportion of patients that achieve Urine Protein Creatinine Ratio (UPCR) \<=0.5 mg after initiating LUPKYNIS by race, ethnicity, and previous LN treatment.
LUPKYNIS utilization patterns
时间窗: 12 months (1 year) to 60 months (5 years)
The proportion of patients that had their first Urine Protein Creatinine Ratio (UPCR) \>0.5 mg within 6 months of initiating LUPKYNIS.
次要结局
未报告次要终点