. 2023 Mar 4;8(5):1043–1056. doi: 10.1016/j.ekir.2023.02.1086

Table 1.

Comparison of key eligibility criteria for PROTECT and other contemporary phase 3 trials recruiting participants with IgAN

Parameter	PROTECT	STOP-IGAN²³^,²⁴	TESTING²⁵^,²⁶	DAPA-CKD²⁷^,²⁸	NefIgArd²⁹
Study drug	Sparsentan	Supportive care + Immunosuppression	Methylprednisolone	Dapagliflozin	Nefecon
Comparator	Irbesartan	Supportive care (ACEi/ARB/Statin)	Placebo	Placebo	Placebo
Patients with IgAN	404^a	162^a	503	270^a	360
Age, years	≥18	≥18 to ≤70	≥14	≥18	≥18
Biopsy-proven IgAN requirement	Yes At any time in the past	Yes At any time in the past	Yes At any time in the past	No	Yes Within the past 10 yr
Proteinuria	Protein excretion ≥1 g/d	Protein excretion ≥0.75g/d to ≤3.5 g/d	Protein excretion ≥1 g/d	UA/C ≥200 mg/g to ≤5000 mg/g	Protein excretion ≥1 g/d or UP/C ≥0.8 g/g
eGFR or creatinine clearance, ml/min/1.73 m²	≥30	≥30 to <90	≥20 to ≤120	≥25 to ≤75	≥35 to ≤90
Systolic/diastolic blood pressure, mm Hg	≤150/100	No criterion preventing inclusion	≤160/110	No criterion	≤140/90
Optimized RAAS inhibition	Yes Stable MTD or MLD of ACEi and/or ARB at ≥50% MLD for ≥12 wks	Yes MTD or MLD of ACEi and/or ARB, achieved through dedicated 6-mo run-in period	Yes MTD of ACEi and/or ARB	Stable dose of ACEi and/or ARB for ≥4 wks	Yes Stable MTD or MLD of ACEi and/or ARB ≥3 mo

ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; eGFR, estimated glomerular filtration rate; IgAN, immunoglobulin A nephropathy; MLD, maximum labeled dose; MTD, maximum tolerated dose; RAAS, renin-angiotensin-aldosterone system inhibition; UA/C, urine albumin-to-creatinine ratio; UP/C, urine protein-to-creatinine ratio.

Randomized and received study drug.