Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 2:49 PM
Study NCT ID:
NCT03104166
Status:
COMPLETED
Last Update Posted:
2020-01-23
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulation of Vascular Calcification in Chronic Dialysis Patients
Sponsor:
Charite University, Berlin, Germany
Organization:
Study Overview
Official Title:
Modulation of Vascular Calcification in Chronic Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ModuVas
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.
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 Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: