A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)

Sponsor
argenx
Study ID
NCT05810961
Phase
PHASE2
Status
Terminated

Conditions

  • Membranous Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod IV — BIOLOGICAL
    infusion of efgartigimod
  • placebo — OTHER
    infusion of placebo

Study Details

To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).

Key Dates

Start date
Feb 20, 2023
Status verified
Nov 2024
Primary completion
Aug 5, 2024
Completion
Aug 5, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod IV
    patients receiving infusions of efgartigimod
  • Experimental: placebo
    patients receiving infusions of placebo

Primary Outcome Measure

Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in anti- PLA2R antibody (Ab) seropositive population [ Time Frame: up to 24 weeks ]

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