Modulation of Vascular Calcification in Chronic Dialysis Patients

Vascular Calcification Clinical Trial

— ModuVas  

Official title:

Modulation of Vascular Calcification in Chronic Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104166
• Other study ID #: ModuVas
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: January 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Vascular Calcification

Intervention

Device:
• Medium Cut-Off (MCO) 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.
• High-Flux dialysis membrane
Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.

Locations

Country	Name	City	State
Germany	Charité Virchow	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six months
Secondary	Aortic Pulse wave velocity	Aortic Pulse wave velocity will be determined using the Vicorder Device.	Six months
Secondary	Calcification propensity	Calcification propensity will be determined as described earlier. (PMID: 24179171)	Six months
Secondary	Physical activity level	Physical activity level will be monitored for one week before and after treatment using an activity tracker.	Six months
Secondary	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.	Six months