primary membranous nephropathy with moderate risk
Conditions
Interventions
control group:
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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.; | — |
Countries
China
Contacts
Public ContactJianghua Chen
Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University?
Outcome results
None listed