New kidney drug YK012 enters first human tests
NCT ID NCT06982729
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary membranous nephropathy are added.
Genom att skicka in godkänner du våra Användarvillkor
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
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100034, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new tool to predict kidney failure risk in membranous nephropathy?
- Can engineered immune cells tackle a tough kidney disease?
- Can a smarter antibody outsmart a kidney disease that resists standard treatment?
- Can engineered immune cells tame autoimmune kidney disease?
- Can a pill calm the immune attack on kidneys?
- Can a gene-silencing drug calm overactive complement in kidney disease?