Table 2.
Study Phase | Screening | Wash in Period | Intervention | Wash out | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Visits | Visit 1 | Visit 2 | Visit 3 Baseline | Visit 4 | Visit 5 | Visit 6 | Visit 7 | Visit 8 | Visit 9 | Visit 10 | Visit 11 |
Week −1 | Wk 0 | Wk 4 | Wk 6 | Wk 8 | Wk 12 | Wk 16 | Wk 20 | Wk 24 | Wk 28 | Wk 32 | |
Screening | |||||||||||
Inclusion/exclusion criteria | X | X | |||||||||
Informed Consent | X | ||||||||||
24 h Urine collection | X | ||||||||||
Demographics/Medical History/Physical exam | X | ||||||||||
Primary Outcome | |||||||||||
Centrally tested serum albumina | X | X | X | X | X | X | X | X | X | X | |
Trial Intervention Use | |||||||||||
High Flux (Revaclear) dialyser | X | X | X | X | |||||||
Mid cut-off (Theranova) dialyser | X | X | X | X | X | X | X | X | |||
Clinical assessments | |||||||||||
Erythropoietin Resistance Index | X | X | X | ||||||||
Weight (pre & post HD) | X | X | X | X | |||||||
Duration of HD | X | X | X | X | |||||||
Restless Leg Symptom Rating Scale | X | X | X | ||||||||
Malnutrition Inflammation Score | X | X | X | ||||||||
Edmonton Symptom Assessment System Revised | X | X | X | ||||||||
6 min walk testa | X | X | X | ||||||||
Adverse events (as required) | X | X | X | X | X | X | X | X | X | X | |
Local lab assessments | |||||||||||
Albumina | X | X | X | X | X | X | X | X | X | X | |
Urea (pre & post HD) | X | X | X | ||||||||
Haemoglobin, transferrin, INR, APTTa | X | X | X | ||||||||
Central lab samples | |||||||||||
Lambda free light chainsa | X | X | X | X | X | X | X | X | X | X | |
Κappa-FLC, β2Microglobulin, high sensitivity C-Reactive Proteina | X | X | X | ||||||||
Substudy – Matrix Gla Protein, fetuin A, CPP, FGF23a | X | X | X |
a Collected pre-dialysis prior to the mid-week HD
APTT activated partial thromboplastin time, CPP calciprotein particles, FGF23 Fibroblast growth factor23, HD haemodialysis, INR international normalised ratio