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. 2018 Apr 17;19:89. doi: 10.1186/s12882-018-0883-8

Table 2.

Visit schedule for REMOVAL-HD study

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