Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.
While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue. Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included. With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Extended HD with theranova
Online hemodiafiltration
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Change in cardiovascular surrogate marker
Brachial-ankle pulse wave velocity (m/s)
Time frame: 0, 6, 12 months
Change in cardiac surrogate marker #1
CT coronary calcium scoring (score)
Time frame: 0, 6, 12 months
Change in cardiac surrogate marker #2
Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2).
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #1
Plasma levels of BNP (pg/ml)
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #2
Plasma levels of NT-proBNP (pg/ml)
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #3
Plasma levels of hsCRP (mg/dl)
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #4
Plasma levels of troponin-I (ng/ml)
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #5
Plasma levels of troponin-T (ng/ml)
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #6
Plasma levels of IL-6 (pg/ml)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0, 6, 12 months
Patient-reported outcomes #1
Dialysis symptom index (score)
Time frame: 0, 6, 12 months
Patient-reported outcomes #2
Degree of fatigue after dialysis (scale from 0 to 10)
Time frame: 0, 6, 12 months
Patient-reported outcomes #3
Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis)
Time frame: 0, 6, 12 months