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Randomized controlled clinical trial of WYJB in the treatment of membranous nephropathy

Registration number：

ITMCTR2025000461

Date of Last Refreshed on：

2025-03-04

Date of Registration：

2025-03-04

Registration Status：

Prospective registration

Public title：

Randomized controlled clinical trial of WYJB in the treatment of membranous nephropathy

English Acronym：

Scientific title：

Randomized controlled clinical trial of WYJB in the treatment of membranous nephropathy

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Shuxian Huang

Study leader：

Baoli Liu

Applicant telephone：

+86 15501180122

Study leader's telephone：

+86 135 2220 4561

Applicant Fax：

Study leader's fax：

Applicant E-mail：

huangshuxian98@163.com

Study leader's E-mail：

polyliu2000@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Beijing Hospital of Traditional Chinese Medicine No.23 Back Street Art Museum Dongcheng

Study leader's address：

Beijing Hospital of Traditional Chinese Medicine No.23 Back Street Art Museum Dongcheng

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Approved by ethic committee：

Approved No. of ethic committee：

2024BL02-044-02

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University

Date of approved by ethic committee：

2024/9/11 0:00:00

Contact Name of the ethic committee：

Liu Sheng

Contact Address of the ethic committee：

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Contact phone of the ethic committee：

01087906734

Contact email of the ethic committee：

liusheng@bjzhongyi.com

Primary sponsor：

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Primary sponsor's address：

Beijing Hospital of Traditional Chinese Medicine No.23 Back Street Art Museum Dongcheng District Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Dongcheng City

Institution
hospital：

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Address：

Beijing Hospital of Traditional Chinese Medicine No.23 Back Street Art Museum Dongcheng District Beijing

Source(s) of funding：

Beijing Municipal Health Commission

Target disease：

membranous nephropathy

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

① To confirm the clinical efficacy and safety of Mafuyishen recipe for MN patients through randomized controlled trials; ② Compared with the control group (tacrolimus) it is confirmed that the efficacy of Mafuyishen recipe is not inferior to that of the first-line treatment scheme of western medicine and its safety is better than that of the first-line treatment scheme of western medicine; ③ To explore the possibility of treating MN with traditional Chinese medicine instead of immunosuppressant.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Age 18-80 male or female; (2) Meet the diagnostic criteria for primary membranous nephropathy in Western medicine; (3) Kidney function meets the criteria for chronic kidney disease stage 2 or higher i.e. estimated glomerular filtration rate (eGFR) according to the CKD-EPI formula is ≥60 mL/min/1.73m2; (4) According to the 2021 KDIGO guidelines the risk stratification assessment for membranous nephropathy is classified as moderate risk with best supportive treatment for 3 months or more before enrollment and 24-hour urine protein excretion of ≥3.5g and urine protein reduction of ≤50%; or if the patient has already received full-course best supportive treatment in the past and 24-hour urine protein excretion still meets the above criteria the patient may be enrolled upon confirmation by the investigator; (5) The patient voluntarily participates in this study and signs an informed consent form.

Exclusion criteria：

(1) Progressive membranous nephropathy (defined as: progressive decline of renal function and eGFR decreased by more than 30% during two follow-up periods (3 months); Or renal biopsy showed necrotizing capillary inflammation and > 50% new moon formation). (2) Patients with other kidney diseases such as IgA nephropathy hypertensive benign arteriolar nephrosclerosis diabetic nephropathy etc. (3) Have received any of the following therapeutic drugs for membranous nephropathy: ① Have received immunosuppressants such as prednisone (or equivalent drugs) mycophenolate mofetil tacrolimus cyclosporine azathioprine tripterygium wilfordii and hydroxychloroquine (including but not limited to immunosuppressants such as chemical drugs Chinese patent medicines or Chinese herbal medicines except alkylating agents and immunosuppressants against CD20 and B-cell clearance drugs) within 3 months before screening; ② Patients were treated with alkylating agents (such as cyclophosphamide and chlorambucil) within 6 months before screening; ③ Have received any anti-CD20 therapy or any drugs with B cell clearance within 9 months before screening; (4) Other indexes of rheumatic immune diseases are abnormal; (5) Persistent bacterial or viral infection such as active hepatitis B; (6) Abnormal liver function with alanine aminotransferase (ALT) exceeding the upper limit of normal by more than 5 times (only at the time of enrollment screening); (7) Patients with a history of malignant tumor HIV infection mental illness acute central nervous system diseases and severe gastrointestinal diseases; (8) Combined with life-threatening complications such as severe infection; (9) Patients with cardiovascular diseases (such as coronary heart disease) arrhythmia cerebrovascular diseases (such as cerebral hemorrhage and cerebral infarction) or serious organ diseases and dysfunction (including but not limited to cor pulmonale cardiac insufficiency hepatic insufficiency etc.) or diabetes; (10) those who are known to be allergic to the components of the Chinese medicine used; (11) Pregnant and lactating women for women of childbearing age who have not undergone sterilization: do not agree to use appropriate methods of contraception such as oral contraceptives intrauterine devices or barrier contraception combined with spermicide during the treatment period and at least 12 months after the last administration of the research drug; (12) researcher who are undergoing other clinical trial; (13) Other circumstances that the researcher thinks are not suitable for this study.

Study execute time：

From 2024-01-01

To      2026-12-31

Recruiting time：

From 2025-03-12

To      2025-12-31

Interventions：

65

Group：

Control group

Sample size：

Intervention：

The control group was given tacrolimus monotherapy plus the basic treatment plan. Tacrolimus capsules were started at 0.05 mg/kg/d, taken orally twice a day, with a maximum dose of 6 mg/d. For those who achieved complete remission, the dosage was gradually reduced; for those who responded to the treatment, it was continued for 12 months, then gradually reduced over the next 6 months, and discontinued at 18 months.

Intervention code：

65

Group：

trial group

Sample size：

Intervention：

The experimental group was given Ma Fu Yishen granule + basic treatment plan. Experimental group took Chinese medicine compound granules orally, once in the morning and once in the evening, 1 bag each time. The reduction plan was adopted for those who achieved complete remission. Those who responded continued treatment until 12 months later and stopped taking the drug for 18 months. Non-responders were treated with a frequency dose scheme.

Intervention code：

Total sample size ： 130

Countries of recruitment
and research settings：

Country：

China

Province：

Beijing

City：

Shunyi District

Institution/hospital：

Shunyi Hospital Beijing traditional Chinese medicine hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Dongcheng District

Institution/hospital：

Beijing traditional Chinese medicine hospital affiliated to Capital Medical University

Level of the institution：

Tertiary A

Country：

China

Province：

Hebei Province

City：

Tangshan City

Institution/hospital：

Tangshan Fengrun District Hospital of Traditional Chinese medicine

Level of the institution：

Secondary A

Country：

China

Province：

Shanxi Province

City：

Weinan City

Institution/hospital：

Weinan Central Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Xicheng District

Institution/hospital：

Peking University Peoples Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Fengtai District

Institution/hospital：

Beijing Tiantan Hospital Capital Medicine University

Level of the institution：

Tertiary A

Outcomes：

Outcome：

estimated glomerular filtration rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

creatinine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Detection by biochemical analyzer

Outcome：

blood coagulation function test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Total cholesterol

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Detection by biochemical analyzer

Outcome：

TCM Symptom Score

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

TCM Symptom Score Scale (ask the patient)

Outcome：

albumin

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Detection by biochemical analyzer

Outcome：

Routine Blood Test

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

Clinical remission rate

Type：

Primary indicator

Measure time point of outcome：

The 24th month

Measure method：

Outcome：

Cytokine

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Liver function (aminotransferases)

Type：

Adverse events

Measure time point of outcome：

Measure method：

Detection by biochemical analyzer

Outcome：

Clinical remission rate

Type：

Secondary indicator

Measure time point of outcome：

The 12th and 18th months

Measure method：

Outcome：

HbA1c

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

triglyceride

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Detection by biochemical analyzer

Outcome：

Electrocardiogram

Type：

Adverse events

Measure time point of outcome：

Measure method：

Electrocardiogram Testing Machine

Outcome：

Anti-PLA2R

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

ELISA

Outcome：

routine urianlysis

Type：

Adverse events

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

Blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

Urine

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

faeces

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

Clinical trial central randomization system (IWRS system for short) was used to implement center stratification and Linglong IWRS random system was used to generate random coding table of subjects and random coding table of drugs. The subjects were assigned to the experimental group and the control group according to the ratio of 1:1. When the screened subjects are eligible to join the group the researchers of the sub-center will log in to the IWRS system and input the basic information of the subjects according to the system prompts. Each subject's ID code and random number are unique and bound to each other. After generating the random number the drug manager logs into the IWRS system again to obtain the distribution results and distribute the drugs to the subjects.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

In this trial electronic data (EDC) system was used to collect clinical trial data. The main processes of data management are listed below. See the data management plan (DMP) for details. As a guiding document for data management DMP is written by data administrator (DM) and approved by the applicant. Data management will be carried out according to the time content and method defined by DMP.

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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