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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048382
Enrollment
Unknown
Registered
2021-07-06
Start date
2021-07-01
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic membranous nephropathy

Interventions

Sponsors

Department of Nephrology, Sichuan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Absolute decrease in urinary protein quantification relative to baseline;

Secondary

MeasureTime frame
Absolute decrease in the ratio of urinary albumin to creatinine in morning urine relative to baseline;Percentage of patients who met criteria for clinical efficacy;Compound renal endpoint events;

Countries

China

Contacts

Public ContactFeng Yunlin

Department of Nephrology, Sichuan Provincial People's Hospital

fengyunlin@med.uestc.edu.cn+86 17708130285

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026