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

• Register: ITMCTR
• Last refreshed on: 20 February 2023
• Main ID: ITMCTR2200005709
• Date of registration: 2021-07-06
• Prospective Registration: No
• Primary sponsor: Department of Nephrology, Sichuan Provincial People's Hospital
• Public title: Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial
• Scientific title: Efficacy and Safety of Tripterygium Wilfordii Multiglycosides in Idiopathic Membranous Nephropathy: Protocol for An Open-label Randomized Controlled Clinical Trial
• Date of first enrolment: 2021-07-01
• Target sample size: Experimental group:18;Control group:18;
• Recruitment status: Recruiting
• URL: http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=df57d832-32bf-483c-9c61-544adb2e9d9a
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Feng Yunlin
• Affiliation: Department of Nephrology, Sichuan Provincial People's Hospital

• Name: Geng Chanyu
• Affiliation: Department of Nephrology, Sichuan Provincial People's Hospital

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic membranous nephropathy

Intervention(s)

Experimental group:On the basis of ACEI/ARB, tripterygium wilfordii polyglycoside tablets were added;Control group:The original dose of ACEI/ARB was used for treatment;

Primary Outcome(s)

Absolute decrease in urinary protein quantification relative to baseline;

Secondary Outcome(s)

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;

Secondary ID(s)

ChiMCTR2200005709

ChiCTR2100048382

Source(s) of Monetary Support

The study is financially supported by the PRO Run Foundation of the Nephrology Group of the Medical Evidence-based Special Committee of the Chinese Physicians Association.

Ethics review

Status: Approved
Approval date: 08/06/2021
Contact:

Yong Zhengping

[phone]