A Phase I Study of YK012 in Primary Membranous Nephropathy (NCT07234474) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study of YK012 in Primary Membranous Nephropathy
66 participantsStarted 2026-10
Plain-language summary
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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Age 18-80 (inclusive), both gender.
* Diagnosed with primary (idiopathic) membranous nephropathy by renal biopsy within 10 years.
* Participants who meet the criteria of very high-risk primary (idiopathic) membranous nephropathy based on 2021 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for the Management of Glomerular Diseases and who have failed available therapies for the treatment of pMN.
* eGFR estimated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula is ≥45 mL/min/1.73 m².
* If taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin II receptor blocker (ARB), or Sodium-Glucose Co-Transporter 2 (SGLT-2) inhibitor, the medication dosage must have been stable (≤50% change in dose) for at least 4 weeks prior to screening and continue being stable prior to the initiation of the investigational product.
* Laboratory tests within 7 days prior to enrollment meet the pre-defined criteria.
* Be able to understand and voluntarily participate in this clinical trial with written signed informed consent and available for scheduled visits, treatments, examinations, and other study procedures.
Exclusion Criteria:
* Diagnosed with secondary membranous nephropathy.
* Any prior receipt of protocol-specified pharmacological treatment for membranous nephropathy.
* History of malignant tumor within 5 years prior to screening.
* Poorly controlled hypertension.
* Participants with severe renal in…
What they're measuring
1
Ia: Dose-Limiting Toxicity (DLT)
Timeframe: up to 28 days after the first dose
2
Adverse Event (AE)
Timeframe: From the first induction to the end of the trial at 53 weeks
3
Severe Adverse Event
Timeframe: From the first induction to the end of the trial at 53 weeks