Clinical Trial: Modulation of Vascular Calcification in Chronic Dialysis Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Modulation of Vascular Calcification in Chronic Dialysis Patients
Brief 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.
Detailed Summary:
Sponsor: Charite University, Berlin, Germany
Current Primary Outcome: In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months [ Time Frame: Six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Aortic Pulse wave velocity [ Time Frame: Six months ]Aortic Pulse wave velocity will be determined using the Vicorder Device.
- Calcification propensity [ Time Frame: Six months ]Calcification propensity will be determined as described earlier. (PMID: 24179171)
- Physical activity level [ Time Frame: Six months ]Physical activity level will be monitored for one week before and after treatment using an activity tracker.
- 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 [ Time Frame: Six months ]Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum.
Original Secondary Outcome: Same as current
Information By: Charite University, Berlin, Germany
Dates:
Date Received: April 3, 2017
Date Started: July 1, 2017
Date Completion: December 31, 2018
Last Updated: April 7, 2017
Last Verified: April 2017