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50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment.
Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.
Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining.
Primary endpoint:
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8.
Secondary Endpoints:
Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months
Cell culture: Incubation of VSMC with serum samples obtained after 6 months
The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCO | Experimental | Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes. |
|
| High-Flux | Active Comparator | Patients will be treated thrice weekly with High-Flux Dialysis membranes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium Cut-Off (MCO) dialysis membrane | Device | Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane. |
| Measure | Description | Time Frame |
|---|---|---|
| In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months | Serum samples will be drawn at the beginning of the trial and after six months treatment with either High-Flux or Medium Cut-Off filters. Vascular smooth muscle cells will be incubated with thee serum samples and calcification will be assessed with Alkaline Phosphatase/ WST8 | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Aortic Pulse wave velocity | Aortic Pulse wave velocity will be determined using the Vicorder Device. | Six months |
| Calcification propensity | Calcification propensity will be determined as described earlier. (PMID: 24179171) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Virchow | Berlin | 13353 | Germany |
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| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| High-Flux dialysis membrane | Device | Control: Patients will be treated with a CE-certified High-Flux dialysis membrane. |
|
| Six months |
| Physical activity level | Physical activity level will be monitored for one week before and after treatment using an activity tracker. | Six months |
| Cell culture: Incubation of VSMC with serum samples and assessment of • Alizarin staining/WST-8 • Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants • Apoptosis | Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum. | Six months |