Trials / Completed
CompletedNCT03104166
Modulation of Vascular Calcification in Chronic Dialysis Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Charite University, Berlin, Germany · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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 * Alizarin staining/WST-8 * Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants * Apoptosis The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Medium Cut-Off (MCO) dialysis membrane | Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane. |
| DEVICE | High-Flux dialysis membrane | Control: Patients will be treated with a CE-certified High-Flux dialysis membrane. |
Timeline
- Start date
- 2018-01-22
- Primary completion
- 2019-08-30
- Completion
- 2019-08-31
- First posted
- 2017-04-07
- Last updated
- 2020-01-23
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03104166. Inclusion in this directory is not an endorsement.