Table 1.

DUPLEX key inclusion criteria

1.	The patient or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent, and, when required, the patient is willing to provide assent before any screening procedures.
2.	The patient has biopsy-proven FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS.
3.	Sites within the United States: The patient is male or female aged 8 to 75 yr, inclusive, weighing ≥20 kg at screening. Sites outside the United States: The patient is male or female aged 18 to 75 yr, inclusive, weighing ≥20 kg at screening.
4.	The patient has a UP/C ≥1.5 g/g at screening.
5.	The patient has an eGFR ≥30 ml/min per 1.73 m2 at screening.
6.	WOCBP must agree to the use of 1 highly reliable method of contraception from 7 d before the first dose of study medication until 90 d after the last dose of study medication and simultaneous use of 1 additional barrier method of contraception during sexual activity from day 1/randomization until 90 d after the last dose of study medication.a

DUPLEX, A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS; eGFR, estimated glomerular filtration rate; FSGS, focal segmental glomerulosclerosis; ET_A, endothelin type A; ET_B, endothelin type B; UP/C, urinary protein-to-creatinine ratio; WOCBP, women of childbearing potential.

^aContraception requirements are based on the fetal harm effects associated with selective and nonselective ET_A/ET_B receptor antagonists and angiotensin receptor blockers.