Actively Recruiting
Study of YK012 in Primary Membranous Nephropathy
Led by Excyte Biopharma Ltd · Updated on 2025-11-17
72
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of YK012 in Primary Membranous Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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/1.73m�b2 as calculated by the CKD-EPI equation.
- Stable dose of ACE inhibitor, ARB, or SGLT-2 inhibitor for at least 4 weeks prior to enrollment if currently taking.
- Laboratory test results meeting predefined criteria within 7 days prior to enrollment.
- Ability to understand, voluntarily consent, and comply with study procedures.
You will not qualify if you...
- Diagnosis of secondary membranous nephropathy.
- Prior pharmacological treatment for membranous nephropathy.
- History of malignancy within 5 years prior to enrollment.
- Poorly controlled hypertension at enrollment.
- Severe renal dysfunction with dialysis or kidney transplantation within 6 months prior to enrollment.
- Prior kidney biopsy-confirmed diabetic nephropathy.
- Severe or chronic infections within 6 months before enrollment or current need for systemic antibiotics or antivirals.
- Cardiovascular or cerebrovascular hospitalization within 6 months prior to enrollment.
- Severe or poorly controlled comorbidities affecting protocol compliance or efficacy evaluation.
- Active tuberculosis with documented infection.
- History of solid organ or bone marrow transplantation.
- Live vaccination, major surgery, or participation in other trials with investigational drugs within 28 days prior to enrollment.
- Positive HBsAg, HBcAb with detectable HBV DNA, HCV antibody positive, HIV seropositive, or Treponema pallidum antibody positive.
- CD4+ T lymphocyte count below 200 cells/bcL.
- Known hypersensitivity to any component of YK012.
- Pregnancy, breastfeeding, positive pregnancy test at screening, plans to become pregnant during or 12 months after study, or unwillingness to use contraception during study and 12 months thereafter.
- Other conditions judged by investigator as unsuitable for participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
M
Minghui Zhao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here