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Modulation of Vascular Calcification in Chronic Dialysis Patients (ModuVas)

Primary Purpose

Vascular Calcification

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Medium Cut-Off (MCO) dialysis membrane
High-Flux dialysis membrane
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Calcification

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité Virchow

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MCO

High-Flux

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2017
Last Updated
January 21, 2020
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03104166
Brief Title
Modulation of Vascular Calcification in Chronic Dialysis Patients
Acronym
ModuVas
Official Title
Modulation of Vascular Calcification in Chronic Dialysis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Calcification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCO
Arm Type
Experimental
Arm Description
Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.
Arm Title
High-Flux
Arm Type
Active Comparator
Arm Description
Patients will be treated thrice weekly with High-Flux Dialysis membranes.
Intervention Type
Device
Intervention Name(s)
Medium Cut-Off (MCO) dialysis membrane
Intervention Description
Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane.
Intervention Type
Device
Intervention Name(s)
High-Flux dialysis membrane
Intervention Description
Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.
Primary Outcome Measure Information:
Title
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
Description
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
Secondary Outcome Measure Information:
Title
Aortic Pulse wave velocity
Description
Aortic Pulse wave velocity will be determined using the Vicorder Device.
Time Frame
Six months
Title
Calcification propensity
Description
Calcification propensity will be determined as described earlier. (PMID: 24179171)
Time Frame
Six months
Title
Physical activity level
Description
Physical activity level will be monitored for one week before and after treatment using an activity tracker.
Time Frame
Six months
Title
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
Description
Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Charité Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Modulation of Vascular Calcification in Chronic Dialysis Patients

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