Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration (CARTOON)

Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration

Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial

Samsung Medical Center, Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Baxter Healthcare Corporation

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.

End-stage renal disease, Medium cut-off dialyzer, Hemodiafiltration, Cardiovascular, Pulse wave velocity

Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis)

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

Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310. Erratum In: Nephrol Dial Transplant. 2021 Jul 23;36(8):1555-1556.