Table 2.

DUPLEX key exclusion criteria^a

1.	The patient has FSGS secondary to another condition.
2.	The patient is ≥18 yr of age and has positive findings on serological tests that, in the investigator’s opinion, are diagnostic of another primary or secondary glomerular disease.b
3.	The patient has a history of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus or nonfasting blood glucose >180 mg/dl at screening.
4.	The patient has undergone any organ transplantation, with the exception of corneal transplants, or has received certain immunosuppressive medications.
5.	The patient has a documented history of heart failure, coronary artery disease, or cerebrovascular disease.
6.	The patient has significant liver disease.
7.	The patient is positive at screening for HIV or markers indicating acute or chronic hepatitis B infection or hepatitis C infection.
8.	The patient has a history of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 yr.
9.	The patient has disqualifying laboratory abnormalities during a screening, including hematocrit value <27%, hemoglobin value <9 g/dl, potassium value >5.5 mEq/l, or alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of the normal range.
10.	The patient is extremely obese (i.e., ≥18 yr of age with a BMI >40 kg/m2 or is <18 yr of age with a BMI in the 99th percentile plus 5 units at screening), in whom, in the investigator’s opinion, there is a causal relationship between obesity and development of the FSGS lesion.
11.	The patient has a history of alcohol or illicit drug-use disorder.
12.	The patient has a history of serious side effect or allergic response to any angiotensin II antagonist or endothelin receptor antagonist.
13.	The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.c
14.	The patient, in the opinion of the investigator, is unable to adhere to the requirements of the study, including the ability to swallow the study medication capsules whole.

BMI, body mass index; 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; ET_A, endothelin type A; ET_B, endothelin type B; FSGS, focal segmental glomerulosclerosis.

^aThe exclusion criteria are intended to limit inclusion of patients with known etiology of FSGS (serologies, obesity, viral infections, and diabetic nephropathy); to secure patient safety at baseline (exclusion based on hyperkalemia, liver tests, heart failure and conditions frequently associated with heart failure, worsening of anemia); and other conditions that may interfere with a patient’s appropriate adherence to the study protocol (such as, psychiatric disorders and drug abuse).

^bIncludes antinuclear antibody, antidouble-stranded deoxyribonucleic acid antibodies, complement C3 and C4, antineutrophil cytoplasmic antibody, rheumatoid factor, antiglomerular basement membrane antibodies, any clinically significant abnormalities identified by serum and urine protein electrophoresis, or κ and λ chains.

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