Table 1.

Study Characteristics of the Hi-Lo and PHOSPHATE Clinical Trials

	Hi-Lo Trial	PHOSPHATE Trial
Participating countries	United States	Australia, Canada, New Zealand, United Kingdom
Population	Adult in-center HD patients	Adult in-center HD or PD patients receiving at least one PB agent
High phosphate target	6.5-7.0 mg/dL	6.2-7.7 mg/dL
Low-phosphate target	< 5.5 mg/dL	≤ 4.6 mg/dL
Primary outcome	Hierarchical composite of mortality and all-cause hospitalization	Major adverse cardiovascular eventsa
Secondary outcomes	Individual components of the primary outcome; inpatient hospital days; serum albumin and protein catabolic rates	Individual components of the primary outcome; all-cause mortality; quality of life (EQ5D-5L)
Sample size	4,400	3,600
No. of study sites	120-150	-
Design features	Open-label, cluster-level randomization	Open-label, individual-level randomization
Start of enrollment	March 13, 2020	December 10, 2019
Projected end of study	April 30, 2025	December 31, 2025
Primary sponsor	National Institutes of Health	The University of Queensland

Abbreviations: HD, hemodialysis; PB, phosphate binder; PD, peritoneal dialysis.

^aComposite of cardiovascular death, non-fatal myocardial infarction or coronary revascularization, stroke or peripheral arterial events.