To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).The study comprises a maximum 4-week screening period, a 24-week treatment period, and an 8-week follow-up period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
infusion of efgartigimod
infusion of placebo
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
Change from baseline to week 24 in urine protein creatinine ratio (UPCR) in overall population
Time frame: up to 24 weeks
Proportion of participants achieving complete remission (CR), defined as proteinuria ≤0.3g/24-hour and serum albumin ≥3.5g/dL, at week 24 in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 24 weeks
Time to complete remission (CR) in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 32 weeks
Proportion of participants achieving partial remission (PR), defined as ≥50% reduction in proteinuria from baseline AND final proteinuria between 0.3 to 3.5g/24-hour, at week 24 in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 24 weeks
Time to partial remission (PR) in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 32 weeks
Change from baseline to week 24 in anti-PLA2R Ab in anti-PLA2R Ab seropositive population
Time frame: up to 24 weeks
Change from baseline to week 24 in serum albumin in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 24 weeks
Change from baseline to week 24 in estimated glomerular filtration rate (eGFR) in overall population and anti-PLA2R Ab seropositive population
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Peking University People's Hospital
Beijing, China
Hunan Provincial People's Hospital
Changsha, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Fujian Medical University Union Hospital
Fujian, China
Fuyang People's Hospital
Fuyang, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital, Sun Yat-sen University
Guanzhou, China
The First Affiliated Hospital, Zhejiang University
Hanzhou, China
The Second Hospital of Anhui Medical University
Hefei, China
...and 21 more locations
Time frame: up to 24 weeks
Treatment failure rate during treatment period in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 32 weeks
Incidence of relapse, defined as the development of nephrotic range proteinuria following CR or PR, ie, >3.5g/24-hour throughout the study in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 32 weeks
Efgartigimod serum concentration-time profile in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 32 weeks
changes from baseline in levels of total IgG
Time frame: up to 32 weeks
Incidence of antidrug antibodies (ADA) against efgartigimod in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 32 weeks
Change from baseline in EQ5D-5L score in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 24 weeks
Change from baseline in PROMIS Short form v1.0 Fatigue-4a questionnaire in overall population and anti-PLA2R Ab seropositive population
Time frame: up to 24 weeks