Theranova
DeviceExtended HD with theranova
NCT Number: NCT03448887
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seoul National University Bundang Hospital, Gyeonggi-do, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Extended HD with theranova
Online hemodiafiltration
Time frame: 0, 6, 12 months
Brachial-ankle pulse wave velocity (m/s)
Time frame: 0, 6, 12 months
CT coronary calcium scoring (score)
Time frame: 0, 6, 12 months
Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2).
Time frame: 0, 6, 12 months
Plasma levels of BNP (pg/ml)
Time frame: 0, 6, 12 months
Plasma levels of NT-proBNP (pg/ml)
Time frame: 0, 6, 12 months
Plasma levels of hsCRP (mg/dl)
Time frame: 0, 6, 12 months
Plasma levels of troponin-I (ng/ml)
Time frame: 0, 6, 12 months
Plasma levels of troponin-T (ng/ml)
Time frame: 0, 6, 12 months
Plasma levels of IL-6 (pg/ml)
Time frame: 0, 6, 12 months
Dialysis symptom index (score)
Time frame: 0, 6, 12 months
Degree of fatigue after dialysis (scale from 0 to 10)
Time frame: 0, 6, 12 months
Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis)
Seoul National University Hospital
Other
Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial
Acronym: CARTOON
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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