Efficacy and Safety of Tripterygium hypoglaucum Root Tablet combined with Tacrolimus Therapy in primary membranous nephropathy with moderate risk : a double-blind, randomised, controlled trial

Phase 4

• Conditions: primary membranous nephropathy with moderate risk

• Registration Number: ITMCTR2200005596
• Lead Sponsor: The First Affiliated Hospital, College of Medicine, Zhejiang University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Age 45-75 years old;
2.Those whose clinical manifestation and renal biopsy pathologic diagnosis are PMN with secondary membranous nephropathy excluded;
3.Those who take a stable dose of ACEi and/or ARB and/or statins and/or diuretics in accordance with the maximum dose or maximum tolerated dose recommended by the guidelines for at least 8 weeks, which is defined as a dose change of <25% within 8 weeks;
4.Urinary protein =3.5g/day and <8g/day;
5.Estimated GFR = 60 ml/min/1.73m2;
6.Patients who have signed the informed consent forms.

Exclusion Criteria

1.Those who are secondary cause of MN (eg. hepatitis B, lupus erythematosus, drugs, malignant tumors, etc.);
2.PLA2R antibody > 150 RU/ml;
3.Those whose weight >90KG;
4.Those who have fertility needs;
5.Those who have used immunosuppression in the past 3 months or used CD20 monoclonal antibody treatment within 1 year;
6.Those whose eGFR decrease with unexplained reasons in by 20% within 6 months (The decrease is not caused by PMN);
7.Those who has serious, disabling or life-threatening complications related to PMN;
8.Serum albumin level <20g/L;
9.Those with kidney transplantation;
10.Those who are or plan to become pregnant or breastfeeding;
11.Those who infected by active systemic bacterial, virus (including COVID-19) or fungal infection or suspected infection within 14 days, or history of severe recurrent bacterial infection; or fever = 38° within 7 days; or history of human immunodeficiency virus (HIV) infection; or chronic hepatitis B (HBV) or hepatitis C (HCV) with a clear diagnosis;
12.Those who have obvious liver disease, such as ALT greater than 2 times the upper limit, or total bilirubin greater than 1.5 times the upper limit;
13.Those whose have malignant or uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >110mmHg);
14.Those whose have white blood cell count <3.0×109/L, or hemoglobin <80g/L, or platelets <80×109/L, or other blood system diseases;
15.Those who have a history of diabetes;
16.Those with heart failure (NYHA III-IV grade);
17.Those with severe arrhythmia;
18.Those with stroke, TIA, acute myocardial infarction, unstable angina, or cardiogenic or unexplained syncope occurred;
19.Those with a history of malignant tumors;
20.Those with a history of active peptic ulcer or gastrointestinal bleeding;
21.Those who cannot comply with the research protocol by research sponsor;
22.For security reasons, the research sponsor proposed to stop the study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events of special concern:;The health-related quality of life assessed by EQ-5D questionnaire; The primary outcome measure is complete remission and partial remission at 6 months;

Secondary Outcome Measures

Name	Time	Method
The measure is CR and PR at 3 and 12 months;The changes of urine protein compared to baseline at 3, 6, and 12 months.;The changes of eGFR compared to baseline at 3, 6, and 12 months.;The measure is the median time of CR and PR.;