An interventional study of Medium Cut-Off (MCO) dialysis membrane and High-Flux dialysis membrane in Vascular Calcification, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment
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
The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.
182 studies on the registry are indexed under Calcinosis; 33 are open to participants now.
This study's enrollment of 50 is below the median of 77 across 106 interventional studies indexed under Calcinosis.
Browse Calcinosis studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.
Device: Medium Cut-Off (MCO) dialysis membrane
Patients will be treated thrice weekly with High-Flux Dialysis membranes.
Device: High-Flux 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.
Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after 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
Time frame: Six months
Aortic Pulse wave velocity
Aortic Pulse wave velocity will be determined using the Vicorder Device.
Time frame: Six months
Calcification propensity
Calcification propensity will be determined as described earlier. (PMID: 24179171)
Time frame: Six months
Physical activity level
Physical activity level will be monitored for one week before and after treatment using an activity tracker.
Time frame: Six months
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
Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum.
Time frame: Six months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany