Table 1.

TRACTION-2 novel study design features

Study design feature	Description
Adaptive design	Depending upon the results of a preplanned interim analysis, sample size can be increased and/or enriched for populations more likely to respond to GFB-887 treatment on the basis of baseline urinary Rac1 levels
	Dose for Dose Levels 2 and 3 will be determined based upon the pharmacokinetic determinations performed on an ongoing basis
“Basket” design	Enrollment of patient cohorts across various chronic kidney disease etiologies (DN, FSGS/TR-MCD) to characterize the effect of a single-targeted therapy (GFB-887) in multiple disorders
Patient-focused	Remote study conduct: Assessments at the patient’s home using a home healthcare nurse or using telemedicine options
	Robust evaluation of quality of life scores, symptomatology, and edema

DN, diabetic nephropathy; FSGS, focal segmental glomerulosclerosis; TR-MCD, treatment-resistant minimal change disease.