Comparing Efficacy and Safety of Mescaline Sodium Enteric-coated Tablets vs Morte-mescaline in the Treatment of Adult Lupus Nephritis: A Prospective, Multicenter,Real-world Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 205
- 主要终点
- Total effective rate
研究概览
简要总结
The goal of this prospective, multicenter,real-world study is to To evaluate the efficacy and safety of mescaline sodium enteric-coated tablets versus morte-mescaline in the treatment of adult patients with lupus nephritis under real-life medical conditions.
The main question it aims to answer are: Is the efficacy of mescaline sodium enteric-coated tablets in the treatment of adult patients with lupus nephritis not inferior to morti-mescaline？ Participants will receive induction and maintenance treatment with mescaline sodium enteric-coated tablets and morte-mescaline.Then participants will be followed up at 60, 180, 270 and 540 days of treatment to assess the efficacy and safety of mescaline sodium enteric-coated tablets compared to morte-mescaline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years;
- •Meet the 2019 SLE classification criteria established by EULAR/ACR;
- •Have any of the following clinical and laboratory abnormalities: 1) proteinuria >0.5 g/24h, or urine protein ++++ on random urinalysis, or urine protein/creatinine ratio EE >500 mg/g (50 mg/mmol); 2) cellular tubularity including erythrocyte tubularity, hemoglobin tubularity, granular tubularity, tubular tubularity, or mixed tubularity; 3) active urinary sediment (except 3) active urine sediment (except urinary tract infection, urine leukocytes >5/HPF, urine red blood cells >5/HPF), or erythrocyte tubular, or leukocyte tubular;
- •24h urine protein quantification ≥ 1.0 g;
- •Require long-term treatment with MPA-type drugs (mescaline sodium enteric-coated tablets or morte-mescaline);
- •Singed the informed consent.
排除标准
- •Patients treated with immunosuppressive agents (e.g. CTX, MPA, CNI, etc.) within 30 days
- •Patients with co-morbid severe CNS infections
- •Neutrophil counts <1×103/µl;
- •Glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 ;
- •Glutamic aminotransferase (ALT), glutamic oxalacetic aminotransferase (AST) or total bilirubin > 1.5 x upper limit of normal (ULN);
- •Pregnant or lactating women
- •Presence of other major diseases such as tumors, HIV viral infections, systemic bacterial/fungal/viral infections;
- •Presence of contraindications to glucocorticoids and investigational drugs
- •Any condition that, in the judgment of the investigator, is unstable or may jeopardize the safety of the subject and his or her compliance with the study.
研究组 & 干预措施
Mescaline sodium enteric-coated tablets group
Treating with glucocorticoids + mescaline sodium enteric-coated tablets
(1) Induction period: Prednisone tablets: orally, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mescaline sodium enteric-coated tablets: orally, twice a day, at 720-1440 mg/d, for 3-6 months; (2) Maintenance period: Prednisone tablets 5-7.5 mg/d, mescaline sodium enteric-coated tablets 360-540mg/d, maintenance treatment for 1 year
干预措施: Mescaline sodium enteric-coated tablets (Drug)
Mescaline sodium enteric-coated tablets group
Treating with glucocorticoids + mescaline sodium enteric-coated tablets
(1) Induction period: Prednisone tablets: orally, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mescaline sodium enteric-coated tablets: orally, twice a day, at 720-1440 mg/d, for 3-6 months; (2) Maintenance period: Prednisone tablets 5-7.5 mg/d, mescaline sodium enteric-coated tablets 360-540mg/d, maintenance treatment for 1 year
干预措施: Glucocorticoids (Drug)
Morte-mescaline group
Treating with glucocorticoids + morte-mescaline
- Induction period: Prednisone tablets: oral, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mortifamate: oral, twice a day, dose 1-2 g/d, 3-6 months;
- Maintenance period: Prednisone tablets 5-7.5 mg/d, mortifamate 0.5-0.75 g/d, with maintenance treatment for 1 year.
干预措施: Morte-mescaline (Drug)
Morte-mescaline group
Treating with glucocorticoids + morte-mescaline
- Induction period: Prednisone tablets: oral, recommended dose 0.4-0.8 mg/kg/d, with gradual dose reduction (10% per month) at the end of 3-6 months; mortifamate: oral, twice a day, dose 1-2 g/d, 3-6 months;
- Maintenance period: Prednisone tablets 5-7.5 mg/d, mortifamate 0.5-0.75 g/d, with maintenance treatment for 1 year.
干预措施: Glucocorticoids (Drug)
结局指标
主要结局
Total effective rate
时间窗: 180 days of treatment
(Complete remission + Partial remission) / total number of cases
次要结局
- Overall incidence of adverse events and serious adverse reactions(540 days of treatment)