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Table 2 Visit schedule for REMOVAL-HD study

From: Design and methods of the REMOVAL-HD study: a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients

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

 
  1. a Collected pre-dialysis prior to the mid-week HD
  2. APTT activated partial thromboplastin time, CPP calciprotein particles, FGF23 Fibroblast growth factor23, HD haemodialysis, INR international normalised ratio