Table 2.

Schedule of events

	Study period
	Prescreening	Baseline/screening	Visit 1–12
Months	−12 to 0	0	1–12
Study procedures/assessments
Consent		X
Inclusion/exclusion criteria	X	X
Demographics, medical history, physical examination, height		X
Randomisation		X
Rescreening*		X
Concomitant medications -diuretics, erythropoietin stimulating agents, antihypertensive, phosphate binders		X	X
Monthly dialysis blood tests		X	X
Monthly dialysis adequacy assessments		X	X
Pre-HD1 urea, post-HD1 urea, pre-HD2 urea, post-HD2 urea†	X	X	X
Inter-dialytic urine collection for urea and creatinine clearance measurement		X	X
Frozen samples for β−2 microglobulin and β trace protein		X	X
Bioimpedence measurement		X	X
Safety assessments
Adverse events, serious adverse events, MACE, end points			X
Questionnaires
EQ-5D-5L, IIRS, PHQ9, MoCA, CFS		Months 0, 6, 12

*Patients who fail screening will be eligible for rescreening 1 month later provided their screening urea clearance is >2 mL/min/1.73 m² BSA and the rescreening time point remains within 3 months of HD initiation.

†Dialysis adequacy can be calculated using either post-HD1 urea, pre-HD2 urea, post-HD2 urea or optionally using pre-HD1 urea, post-HD1 urea, pre-HD2 urea.

CFS, Clinical Frailty Score; HD, haemodialysis; IIRS, Illness intrusiveness rating score; MACE, major adverse cardiac events; MOCA, Montreal Cognitive assessment.