Table 3.

Efficacy endpoints

Primary efficacy endpoint	The slope of eGFR, assessed from week 6 to week 108 at the final analysis
Surrogate efficacy endpoint	The proportion of patients achieving a UP/C ≤1.5 g/g and a >40% reduction from baseline in UP/C (i.e., FPRE) at week 36 (interim analysis)
Secondary efficacy endpoints	The percent change in eGFR from week 6 to week 108
	The percent change in eGFR from baseline to 4 wk postcessation of randomized treatment at week 112
Exploratory endpoints	Slope of eGFR assessed from week 6 to week 60
	Absolute and percent change in eGFR from baseline at each visit
	Percent change in eGFR from week 6 at each visit
	Proportion of patients achieving FPRE at each visit
	Percent change in UP/C from baseline at each visit
	Time to achieve FPRE
	Proportion of patients reaching a confirmed 40% reduction in eGFR, ESKD (defined as initiation of renal replacement therapy, kidney transplantation, or sustained eGFR <15 ml/min per 1.73 m2), or death
	Change from baseline in blood pressure at each visit
	Proportion of patients requiring initiation of or intensification in immunosuppressive medication
	Proportion of patients undergoing reduction in immunosuppressive medication
	Change from baseline in quality of life, assessed using patient-reported outcome measures at each visit beginning at week 12
	Frequency and duration of hospitalizations (for any reason and for reasons related to the kidney)
	Trough plasma pharacokinetic concentrations

eGFR, estimated glomerular filtration rate; ESKD, end-stage kidney disease; FPRE, FSGS partial remission endpoint; UP/C, urinary protein-to-creatinine ratio.