Table 4.
TRACTION-2 efficacy endpoints
Primary efficacy endpoint | Percentage change from baseline in UACR or UPCR in patients with DN and FSGS/TR-MCD, respectively |
Secondary efficacy endpoints | Proportions of FSGS/TR-MCD patients achieving a modified partial remission, defined as a UPCR <1.5 g/g and a 40% reduction from baseline at the end of treatment |
Proportions of FSGS/TR-MCD patients achieving a complete remission, defined as UPCR <0.3 g/g at the end of treatment | |
Percentage change from baseline in 24-hour urine protein/albumin excretion | |
Proportion of responders, defined as patients with at least 30%, 40%, and 50% reductions in UACR/UPCR from baseline | |
Proportion of FSGS/TR-MCD patients achieving modified partial remission, complete remission, or a 40% reduction in UPCR from baseline | |
Exploratory efficacy endpoints | Change from baseline in HRQoL scores |
Change from baseline in Nephrotic Syndrome Edema−Clinician Rating Scale |
DN, diabetic nephropathy; eGFR, estimated glomerular filtration rate; FSGS, focal segmental glomerulosclerosis; HRQoL, health-related quality of life; TR-MCD, treatment-resistant minimal change disease; UACR, urinary albumin-to-creatinine ratio; UPCR, urinary protein-to-creatinine ratio.