Overview
This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics and anti-drug antibodies(ADA) of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).
Eligibility
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.


