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New kidney drug YK012 enters first human tests

NCT ID NCT06982729

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage study tests a new drug, YK012, in 72 adults with primary membranous nephropathy, a kidney disease that causes protein leakage. The main goals are to check safety and how the body processes the drug, with a first look at whether it helps reduce protein in urine. Participants must be 18-80, have a confirmed diagnosis within 10 years, and meet specific kidney function criteria.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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 to 80 years

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: * Aged 18 to 80 years (inclusive), regardless of gender. * Kidney biopsy-confirmed diagnosis of primary (idiopathic) membranous nephropathy within the past 10 years. * Elevated 24-hour urine protein, meeting the pre-defined criteria. * Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m² as calculated by the CKD-EPI equation. * If currently taking an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or sodium-glucose cotransporter-2 (SGLT-2) inhibitor, the dose must have been stable for at least 4 weeks prior to enrollment or since initiation of therapy. * Laboratory test results must meet the predefined criteria within 7 days prior to enrollment. * Capable of understanding and voluntarily participating in this clinical trial, having provided written informed consent, and able to comply with scheduled visits, treatments, examinations, and other study procedures as required. Exclusion Criteria: * Diagnosis of secondary membranous nephropathy. * Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy. * History of malignancy within 5 years prior to enrollment. * Poorly controlled hypertension at enrollment. * Severe renal dysfunction with prior dialysis or kidney transplantation within 6 months prior to enrollment. * Prior kidney biopsy-confirmed diagnosis of diabetic nephropathy. * History of severe or chronic infections within the 6 months before enrollment or current need for systemic antibiotic or antiviral therapy. * Cardiovascular or cerebrovascular events requiring hospitalization within 6 months prior to enrollment. * Severe or poorly controlled comorbidities that may affect protocol compliance or efficacy evaluation. * Active Tuberculosis (TB) with documented evidence of infection. * History of solid organ or bone marrow transplantation. * Live vaccination, major surgery, or participated in other clinical trials with investigational drug use within 28 days prior to enrollment. * HBsAg-positive, or HBcAb-positive with detectable HBV DNA above the normal range; HCV antibody-positive; HIV seropositive; Treponema pallidum antibody-positive. * CD4+ T lymphocyte count \<200 cells/μL * Known hypersensitivity to any component of YK012. * Pregnancy, breastfeeding, or positive pregnancy test at screening; or plans to become pregnant during the trial or within 12 months after study completion, or unwillingness to use physical contraceptive methods during the study and for 12 months thereafter. * Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.

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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.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Peking University First Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100034, China

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