A Phase â…¢ Clinical Study of MIL62 in Primary Membranous Nephropathy (NCT05862233) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Phase â…¢ Clinical Study of MIL62 in Primary Membranous Nephropathy
China150 participantsStarted 2023-06-02
Plain-language summary
This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics（PD）and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80;
✓. 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 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;
✓. 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 (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 \< 200 cells/μL;
✕. Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment;