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OpenTrials
Completed

NCT Number: NCT03104166

Modulation of Vascular Calcification in Chronic Dialysis Patients

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.

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Key information

Conditions

Vascular Calcification Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Virchow

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medium Cut-Off (MCO) dialysis membrane

Device

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

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Aortic Pulse wave velocity

    Time frame: Six months

    Aortic Pulse wave velocity will be determined using the Vicorder Device.

  2. Calcification propensity

    Time frame: Six months

    Calcification propensity will be determined as described earlier. (PMID: 24179171)

  3. Physical activity level

    Time frame: Six months

    Physical activity level will be monitored for one week before and after treatment using an activity tracker.

  4. 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: ModuVas

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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