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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Baxter Healthcare Corporation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Extended HD with MCO dialyzer |
|
| Control group | Active Comparator | Online hemodiafiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theranova | Device | Extended HD with theranova |
| |
| Online hemodiafiltration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiovascular surrogate marker | Brachial-ankle pulse wave velocity (m/s) | 0, 6, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cardiac surrogate marker #1 | CT coronary calcium scoring (score) | 0, 6, 12 months |
| Change in cardiac surrogate marker #2 | Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwon Wook Joo, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea | |||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27587605 | Result | 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. |
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| INDUSTRY |
Exploratory, Multicenter, Randomized
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| Device |
Online hemodiafiltration |
|
| 0, 6, 12 months |
| Change in cardiovascular biomarkers #1 | Plasma levels of BNP (pg/ml) | 0, 6, 12 months |
| Change in cardiovascular biomarkers #2 | Plasma levels of NT-proBNP (pg/ml) | 0, 6, 12 months |
| Change in cardiovascular biomarkers #3 | Plasma levels of hsCRP (mg/dl) | 0, 6, 12 months |
| Change in cardiovascular biomarkers #4 | Plasma levels of troponin-I (ng/ml) | 0, 6, 12 months |
| Change in cardiovascular biomarkers #5 | Plasma levels of troponin-T (ng/ml) | 0, 6, 12 months |
| Change in cardiovascular biomarkers #6 | Plasma levels of IL-6 (pg/ml) | 0, 6, 12 months |
| Patient-reported outcomes #1 | Dialysis symptom index (score) | 0, 6, 12 months |
| Patient-reported outcomes #2 | Degree of fatigue after dialysis (scale from 0 to 10) | 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) | 0, 6, 12 months |
| Seoul |
| 03080 |
| South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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