Modulation of Vascular Calcification in Chronic Dialysis Patients (ModuVas)

January 21, 2020 updated by: Daniel Zickler, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charité Virchow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aortic Pulse wave velocity
Time Frame: Six months
Aortic Pulse wave velocity will be determined using the Vicorder Device.
Six months
Calcification propensity
Time Frame: Six months
Calcification propensity will be determined as described earlier. (PMID: 24179171)
Six months
Physical activity level
Time Frame: Six months
Physical activity level will be monitored for one week before and after treatment using an activity tracker.
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
Time Frame: Six months
Additional in vitro calcification parameters will be assessed after incubation of VSMC with patient serum.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 22, 2018

Primary Completion (ACTUAL)

August 30, 2019

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (ACTUAL)

April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ModuVas

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Calcification

Clinical Trials on Medium Cut-Off (MCO) dialysis membrane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe