Modulation of Vascular Calcification in Chronic Dialysis Patients (ModuVas)
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age 18 years an older
- Chronic dialysis patients for at least 3 months
Exclusion criteria
- Serum albumin <32g/L at the last routine albumin measurement
- Pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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