ITMCTR2200005596尚未招募4 期
Efficacy and Safety of Tripterygium hypoglaucum Root Tablet combined with Tacrolimus Therapy in primary membranous nephropathy with moderate risk : a double-blind, randomised, controlled trial
The First Affiliated Hospital, College of Medicine, Zhejiang University0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 45 至 75（—）
- 性别
- All
入选标准
- •1.Age 45-75 years old;
- •2.Those whose clinical manifestation and renal biopsy pathologic diagnosis are PMN with secondary membranous nephropathy excluded;
- •3.Those who take a stable dose of ACEi and/or ARB and/or statins and/or diuretics in accordance with the maximum dose or maximum tolerated dose recommended by the guidelines for at least 8 weeks, which is defined as a dose change of <25% within 8 weeks;
- •4.Urinary protein =3.5g/day and <8g/day;
- •5.Estimated GFR = 60 ml/min/1.73m2;
- •6.Patients who have signed the informed consent forms.
排除标准
- •1.Those who are secondary cause of MN (eg. hepatitis B, lupus erythematosus, drugs, malignant tumors, etc.);
- •2.PLA2R antibody > 150 RU/ml;
- •3.Those whose weight >90KG;
- •4.Those who have fertility needs;
- •5.Those who have used immunosuppression in the past 3 months or used CD20 monoclonal antibody treatment within 1 year;
- •6.Those whose eGFR decrease with unexplained reasons in by 20% within 6 months (The decrease is not caused by PMN);
- •7.Those who has serious, disabling or life-threatening complications related to PMN;
- •8.Serum albumin level <20g/L;
- •9.Those with kidney transplantation;
- •10.Those who are or plan to become pregnant or breastfeeding;
- •11.Those who infected by active systemic bacterial, virus (including COVID-19) or fungal infection or suspected infection within 14 days, or history of severe recurrent bacterial infection; or fever = 38° within 7 days; or history of human immunodeficiency virus (HIV) infection; or chronic hepatitis B (HBV) or hepatitis C (HCV) with a clear diagnosis;
- •12.Those who have obvious liver disease, such as ALT greater than 2 times the upper limit, or total bilirubin greater than 1.5 times the upper limit;
- •13.Those whose have malignant or uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >110mmHg);
- •14.Those whose have white blood cell count <3.0×109/L, or hemoglobin <80g/L, or platelets <80×109/L, or other blood system diseases;
- •15.Those who have a history of diabetes;
- •16.Those with heart failure (NYHA III-IV grade);
- •17.Those with severe arrhythmia;
- •18.Those with stroke, TIA, acute myocardial infarction, unstable angina, or cardiogenic or unexplained syncope occurred;
- •19.Those with a history of malignant tumors;
- •20.Those with a history of active peptic ulcer or gastrointestinal bleeding;
- •21.Those who cannot comply with the research protocol by research sponsor;
- •22.For security reasons, the research sponsor proposed to stop the study.
研究者
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