A Clinical Study of MIL62 in Primary Membranous Nephropathy
Primary Membranous Nephropathy
About this trial
This is an interventional treatment trial for Primary Membranous Nephropathy
Eligibility Criteria
Inclusion Criteria: Age 18-80; Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening; 24 hours urinary protein > 3.5g at initial screening and confirmation assessment; Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2; If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required; Sufficient organ function; Able and willing to provide written informed consent and to comply with the study protocol. Exclusion Criteria: Participants with a secondary cause of MN; Cyclosporine resistance; Received treatment drugs for membranous nephropathy; Concomitant with other serious diseases; Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug; Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA ); Subjects with CD4+ T lymphocyte count < 300 cells/μL; Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment; Subjects with known history of severe allergic reactions to humanized monoclonal antibodies,MIL62,or Cyclosporine; Breastfeeding or pregnant women; Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method Other conditions unsuitable for participation in this study determined by the Investigator.
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MIL62
Cyclosporine