New antibody drug shows promise for tough kidney disease
NCT ID NCT05398653
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new drug, MIL62, in 94 adults with primary membranous nephropathy, a serious kidney condition. The goal was to see if MIL62 is safe and can help reduce protein in the urine better than the standard drug cyclosporine. Participants received either MIL62 or cyclosporine and were followed for up to 104 weeks to check for remission and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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94 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Apr 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult patients, ≥18 years of age; 2. Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening; 3. 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; 4. Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m\^2; 5. Sufficient organ function; 6. 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. Urine protein decreased by \> 50% within 6 months before screening 4. Received treatment drugs for membranous nephropathy 5. Concomitant with other serious diseases 6. Received live vaccination, major surgery (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug 7. 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 8. Participants with CD4+ T lymphocyte count \< 300 cells/μL 9. Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment 10. Participants with known history of severe allergic reactions to humanized monoclonal antibodies, MIL62, or Cyclosporine 11. Breastfeeding or pregnant women 12. Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method 13. Other conditions unsuitable for participation in this study determined by the Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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Other studies related to the condition(s) this trial covers.
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