Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial

Department of Nephrology, Sichuan Provincial People's Hospital0 个研究点开始时间: 待定最近更新: 2023年2月20日

试验速览

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•1.Idiopathic membranous nephropathy was confirmed by renal biopsy pathology or high titer anti-PLA2R antibody;
•2.Aged 18 to 65 years;
•3.Male and female patients of childbearing age have negative pregnancy test results and agree to take contraceptive measures;
•4.After treatment with standard dose of ACEI or ARB for more than 3 months, the quantitative results of 24-hour proteinuria were still between 1.0 and 6.0 g;
•5.EGFR >60 ml/min/1.73 m^2;
•6.Agrees to voluntarily participate in the study and signs an informed consent form.

•1.Glucocorticoids or other immunosuppressants have been used in the past 6 months;
•2.Clinical evidence of secondary membranous nephropathy (tumors, drugs, other autoimmune diseases such as systemic lupus erythematosus, etc.);
•3.Complicated with chronic liver disease, myocardial infarction, stroke, uncontrollable hypertension and diabetes, malignant tumor;
•4.Known allergy to tripterygium wilfordii polyglycosides or contraindications for use;
•5.Female patients who are pregnant (or intend to be pregnant within half a year), breastfeeding or unwilling to take contraceptive measures;
•6.Life expectancy is less than 6 months;
•7.Are currently participating or have participated in other clinical trials within 3 months;
•8.Refuse to sign an informed consent form or are unable or unwilling to comply with a research protocol approved by the researcher;
•9.The researchers believe that it is not suitable to participate in other situations of this study.

发起方

Department of Nephrology, Sichuan Provincial People's Hospital