Primary Membranous Nephropathy
Conditions
Interventions
Control group:Placebo
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent statement ; 2.Age at the time of enrollment is 18 to 70 years old ; 3.Clinical diagnosis of patients with primary membranous nephropathy (according to the 2021 edition of KDIGO guidelines for diagnostic criteria ) ; 4.PLA2R antibody positive ; 5.During the screening period, 24-hour urinary protein = 3.5g / h, and < 8g / 24h ; 6.eGFR = 40 mL / min / 1.73m2 estimated by CKD-EPI; 7.Subjects using RAS blockers need to have a stable dose within 4 weeks before screening ;
Exclusion criteria
Exclusion criteria: 1.Secondary membranous nephropathy such as lupus nephritis and hepatitis B-related nephritis, or combined with other renal diseases diagnosed by renal biopsy ; 2.eGFR 8 % or 64 mmol / mol ) ; 5.Patients with grade III or IV congestive heart failure diagnosed according to the New York Heart Association ( NYHA ) cardiac function classification during the screening period ; 6.Patients with myocardial infarction, acute coronary syndrome, stroke, seizures or thromboembolic events ( such as deep vein thrombosis or pulmonary embolism ) within 26 weeks before the start of the treatment period ; 7.History of immunodeficiency disease or positive HIV test results ; 8.Pregnant or lactating patients and patients with fertility plans during the trial ; 9. patients with a history of malignant tumors, except : tumors that have been determined to have been cured or have been relieved for more than 5 years, skin basal cell or squamous cell carcinoma that has been radically resected, or carcinoma in situ of any part ; 10.Acute or chronic infection requiring treatment ; 1. The use of B cell targeted drugs ( such as rituximab, otozumab, belimumab, alendronab, bortezomib, CD38 monoclonal antibody ) or other biological agents in the past three months ; 12.Subjects who used systemic glucocorticoids or any immunosuppressive agents in the past 4 weeks ; 13.Used any test drug within 28 days before screening, or in the 5 half-life of the test drug ( whichever is longer ) ; 14.Investigators judged that there were other reasons that were not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving complete remission;The changes of 24-hour urinary protein in subjects compared with baseline ;Changes of 24-hour urinary protein at each visit compared with baseline;Changes of serum albumin at each visit compared with baseline;Changes of serum creatinine levels at each visit compared with baseline;The change of PLA2R antibody level compared with baseline; | — |
Countries
China
Contacts
Public ContactXiangmei Chen
Chinese PLA General Hospital
Outcome results
None listed