ModuVas: Modulation of Vascular Calcification in Chronic Dialysis Patients

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT03104166

Collaborator

(none)

Enrollment

Location

Arms

19.3

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Calcification	Device: Medium Cut-Off (MCO) dialysis membrane Device: High-Flux dialysis membrane	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Modulation of Vascular Calcification in Chronic Dialysis Patients

Actual Study Start Date :

Jan 22, 2018

Actual Primary Completion Date :

Aug 30, 2019

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MCO Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.	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.
Active Comparator: High-Flux Patients will be treated thrice weekly with High-Flux Dialysis membranes.	Device: High-Flux dialysis membrane Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.

Arm

Intervention/Treatment

Experimental: MCO

Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.

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.

Active Comparator: High-Flux

Patients will be treated thrice weekly with High-Flux Dialysis membranes.

Device: High-Flux dialysis membrane

Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.

Outcome Measures

Primary Outcome Measures

In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months [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

Secondary Outcome Measures

Aortic Pulse wave velocity [Six months]
Aortic Pulse wave velocity will be determined using the Vicorder Device.
Calcification propensity [Six months]
Calcification propensity will be determined as described earlier. (PMID: 24179171)
Physical activity level [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 [Six months]
Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Virchow	Berlin		Germany	13353

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Zickler, MD, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT03104166

Other Study ID Numbers:

ModuVas

First Posted:

Apr 7, 2017

Last Update Posted:

Jan 23, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Calcinosis

Vascular Calcification

Study Results

No Results Posted as of Jan 23, 2020