Modulation of Vascular Calcification in Chronic Dialysis Patients

NCT03104166 | Completed

• 1 other identifier: ModuVas
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Calcification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Aortic Pulse wave velocity

  Six months

• Calcification propensity

  Six months

• Physical activity level

  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

  Six months

Study Arms (2)

MCO

EXPERIMENTAL

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

Device: Medium Cut-Off (MCO) dialysis membrane

High-Flux

ACTIVE COMPARATOR

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

Device: High-Flux dialysis membrane

Interventions

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.

MCO

High-Flux dialysis membrane DEVICE

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

High-Flux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years an older
• Chronic dialysis patients for at least 3 months

You may not qualify if:

• Serum albumin \<32g/L at the last routine albumin measurement
• Pregnancy

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Virchow

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 7, 2017
• Study Start: January 22, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 31, 2019
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)