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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03104166
Study type Interventional
Source Charite University, Berlin, Germany
Contact
Status Completed
Phase N/A
Start date January 22, 2018
Completion date August 31, 2019

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