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A Clinical Study of MIL62 in Primary Membranous Nephropathy

A Clinical Study of MIL62 in Primary Membranous Nephropathy

Non Recruiting
18-80 years
All
Phase 3

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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:

  1. Age 18-80;
  2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
  3. 24 hours urinary protein > 3.5g at initial screening and confirmation assessment;
  4. Epidermal growth factor receptor (EGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2;
  5. If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
  6. Sufficient organ function;
  7. Able and willing to provide written informed consent and to comply with the study protocol.

Exclusion Criteria:

  1. Participants with a secondary cause of MN;
  2. Cyclosporine resistance;
  3. Received treatment drugs for membranous nephropathy;
  4. Concomitant with other serious diseases;
  5. Received live vaccination, major surgery (other than diagnostic), and participated in other clinical trials within 28 days prior to receiving the first study drug;
  6. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA );
  7. Subjects with CD4+ T lymphocyte count < 300 cells/μL;
  8. Those who have a clear history of tuberculosis or have received anti-tuberculosis treatment;
  9. Subjects with known history of severe allergic reactions to humanized monoclonal antibodies,MIL62,or Cyclosporine;
  10. Breastfeeding or pregnant women;
  11. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
  12. Other conditions unsuitable for participation in this study determined by the Investigator.

Study details
    Primary Membranous Nephropathy

NCT05862233

Beijing Mabworks Biotech Co., Ltd.

20 August 2025

FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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