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New antibody drug shows promise for tough kidney disease

NCT ID NCT05398653

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

94 people

The number who actually took part.

Started

Feb 2022

Finished

Apr 2025

Lead sponsor

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

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.