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 ]

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


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