Status:
COMPLETED
A Phase Ib/ Ⅱ Clinical Study of MIL62 in Primary Membranous Nephropathy
Lead Sponsor:
Beijing Mabworks Biotech Co., Ltd.
Conditions:
Primary Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study was divided into two stages. In the first stage (Phase Ib), 30 subjects were randomly divided into MIL62 600mg, MIL62 1000mg and cyclosporine groups at a ratio of 1:1:1, with 10 subjects in...
Eligibility Criteria
Inclusion
- Adult patients, ≥18 years of age;
- Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening；
- Screening 24-hour urinary protein \>= 5 g after best supportive care for \>= 3 months prior to screening or screening 24-hour urinary protein \> 3.5 g after best supportive care for \>= 6 months prior to screening, or Screening 24-hour urinary protein \> 3.5 g with at least one high-risk factor defined by the protocol;
- Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2；
- Sufficient organ function;
- Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion
- Participants with a secondary cause of MN
- Cyclosporine resistance
- Urine protein decreased by \> 50% within 6 months before screening
- Received treatment drugs for membranous nephropathy
- Concomitant with other serious diseases
- Received live vaccination, major surgery (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug
- Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA levels above the normal range (HBsAg and/or HBcAb-positive patients require regular HBV DNA testing); patients positive for hepatitis C virus (HCV) antibodies; or patients with a positive human immunodeficiency virus (HIV) serology
- Participants with CD4+ T lymphocyte count \< 300 cells/μL
- Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment
- Participants 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
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2025
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05398653
Start Date
February 24 2022
End Date
April 18 2025
Last Update
November 17 2025
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034