Phase
Condition
Idiopathic Membranous Nephropathy
Nephrotic Syndrome
Glomerulonephritis
Treatment
Cyclosporine
MIL62
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-80;
Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior toor during screening;
Screening 24-hour urinary protein >= 5 g after best supportive care for >= 3 monthsprior to screening or screening Screening 24-hour urinary protein > 3.5 g after bestsupportive care for >= 6 months prior to screening, or Screening 24-hour urinaryprotein > 3.5 g with at least one high-risk factor defined by the protocol;
Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2;
If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptorblocker), 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 studyprotocol.
Exclusion
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), andparticipated in other clinical trials within 28 days prior to receiving the firststudy drug;
Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis Bcore antibody (HBcAb), with HBV DNA levels above the normal range (HBsAg and/orHBcAb-positive patients require regular HBV DNA testing); patients positive forhepatitis C virus (HCV) antibodies; or patients with a positive humanimmunodeficiency virus (HIV) serology.
Participants with CD4+ T lymphocyte count < 200 cells/μL;
Those who have a clear history of tuberculosis or have received anti- tuberculosistreatment;
Participants with known history of severe allergic reactions to humanized monoclonalantibodies, MIL62, or Cyclosporine
Breastfeeding or pregnant women;
Childbearing potential and unwillingness or impossibility to comply with ascientifically acceptable birth-control method
Other conditions unsuitable for participation in this study determined by theInvestigator.
Study Design
Connect with a study center
Peking University First Hospital
Beijing,
ChinaSite Not Available

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