Study of YK012 in Primary Membranous Nephropathy
ConditionPrimary Membranous Nephropathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorExcyte Biopharma Ltd
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- YK012
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov