Table 2

Schedule of events

Study period
PrescreeningBaseline/screeningVisit 1–12
Months12 to 001–12
Study procedures/assessments
 Inclusion/exclusion criteriaXX
 Demographics, medical history, physical examination, heightX
 Concomitant medications -diuretics, erythropoietin stimulating agents, antihypertensive, phosphate bindersXX
 Monthly dialysis blood testsXX
 Monthly dialysis adequacy assessmentsXX
 Pre-HD1 urea, post-HD1 urea, pre-HD2 urea, post-HD2 urea†XXX
 Inter-dialytic urine collection for urea and creatinine clearance measurementXX
 Frozen samples for β−2 microglobulin and β trace proteinXX
 Bioimpedence measurementXX
Safety assessments
 Adverse events, serious adverse events, MACE, end pointsX
 EQ-5D-5L, IIRS, PHQ9, MoCA, CFSMonths 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.