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New treatment option for Primary Membranous Nephropathy
Official title Study of YK012 in Primary Membranous Nephropathy
ClinicalTrials.gov ID: NCT06982729
What this study is testing
What is YK012?
YK012 is an investigational medicine, being studied as a potential treatment for primary membranous nephropathy.
Also referred to as YK012 Infusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YK012 in participants with primary membranous nephropathy (PMN).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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 how well it works 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...
- Other conditions deemed by the investigator to make the subject unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.