Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The response rate for major kidney treatments
研究概览
简要总结
The objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. The main question it aims to answer is: What are the response rates of the two drugs for the main renal therapy in the lupus nephritis population? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18 - 65 years old;
- •Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
- •Urine protein quantification ≥ 1g/d, or urine PCR ≥ 1g/g, or qualitative urine protein test in urine routine ≥ 1+;
- •Patients who have been using telitacicept or belimumab for at least 12 weeks.
排除标准
- •Having active central nervous system diseases;
- •eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- •Pregnant women, or those who are about to become pregnant in the near future, or lactating women;
- •Participants who are simultaneously participating in other clinical studies;
- •Patients who have received telitacicept or belimumab treatment for less than 12 weeks.
研究组 & 干预措施
The Telitacicept group
The participants in the study had previously used telitacicept as a therapeutic drug.
The Belimumab group
The participants in the study had previously used belimumab as a therapeutic drug.
结局指标
主要结局
The response rate for major kidney treatments
时间窗: From baseline to the end of 1-year treatment period
1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure.
次要结局
- Complete renal response rate(From baseline to the end of 1-year treatment period)
研究者
Yipeng Liu
Clinical Professor
Qianfoshan Hospital