Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration (CARTOON)
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 years old and older
- Hemodialysis more than 3 months because of end-stage renal disease
- Consent to the study protocol
Exclusion criteria
- Already receiving online hemodiafiltration before study enrollment
- Dialysis schedule other than three times per week (e.g., once per week)
- Receiving concurrent peritoneal dialysis
- Having a plan to receive kidney transplantation within 1 year
- Having multiple myeloma or monoclonal gammopathy
- Having advanced or active malignancy
- Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
- Participating in other clinical trials
Trial design
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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