Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial
- Conditions
- Idiopathic membranous nephropathy
- Registration Number
- ITMCTR2200005709
- Lead Sponsor
- Department of Nephrology, Sichuan Provincial People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absolute decrease in urinary protein quantification relative to baseline;
- Secondary Outcome Measures
Name Time Method Absolute decrease in the ratio of urinary albumin to creatinine in morning urine relative to baseline;Compound renal endpoint events;Percentage of patients who met criteria for clinical efficacy;