Kidney Failure, Chronic, Renal Dialysis
Conditions
Keywords
End-stage renal disease, Medium cut-off dialyzer, Hemodiafiltration, Cardiovascular, Pulse wave velocity
Brief summary
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.
Detailed 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.
Interventions
DEVICETheranova
Extended HD with theranova
DEVICEOnline hemodiafiltration
Online hemodiafiltration
Sponsors
Samsung Medical Center
Seoul St. Mary's Hospital
Seoul National University Bundang Hospital
Baxter Healthcare Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Exploratory, Multicenter, Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiovascular surrogate marker | 0, 6, 12 months | Brachial-ankle pulse wave velocity (m/s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac surrogate marker #2 | 0, 6, 12 months | Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2). |
| Change in cardiovascular biomarkers #1 | 0, 6, 12 months | Plasma levels of BNP (pg/ml) |
| Change in cardiovascular biomarkers #2 | 0, 6, 12 months | Plasma levels of NT-proBNP (pg/ml) |
| Change in cardiovascular biomarkers #3 | 0, 6, 12 months | Plasma levels of hsCRP (mg/dl) |
| Change in cardiovascular biomarkers #4 | 0, 6, 12 months | Plasma levels of troponin-I (ng/ml) |
| Change in cardiac surrogate marker #1 | 0, 6, 12 months | CT coronary calcium scoring (score) |
| Change in cardiovascular biomarkers #6 | 0, 6, 12 months | Plasma levels of IL-6 (pg/ml) |
| Patient-reported outcomes #1 | 0, 6, 12 months | Dialysis symptom index (score) |
| Patient-reported outcomes #2 | 0, 6, 12 months | Degree of fatigue after dialysis (scale from 0 to 10) |
| Patient-reported outcomes #3 | 0, 6, 12 months | Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis) |
| Change in cardiovascular biomarkers #5 | 0, 6, 12 months | Plasma levels of troponin-T (ng/ml) |
Countries
South Korea
Outcome results
None listed