A Phase I Study of YK012 in Primary Membranous Nephropathy
ConditionPrimary Membranous Nephropathy
Trial statusNot yet recruiting
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
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- YK012
Treatment groups
66 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov