Modulation of Vascular Calcification in Chronic Dialysis Patients

Not Applicable

Completed

• Conditions: Vascular Calcification
• Interventions: Device: Medium Cut-Off (MCO) dialysis membrane; Device: High-Flux dialysis membrane

• Registration Number: NCT03104166
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Study Start: 2018-01-22
• Primary Completion: 2019-08-30
• Study Completion: 2019-08-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MCO	Medium Cut-Off (MCO) dialysis membrane	Patients will be treated thrice weekly with Medium Cut-Off Dialysis membranes.
High-Flux	High-Flux dialysis membrane	Patients will be treated thrice weekly with High-Flux Dialysis membranes.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Charité Virchow; 🇩🇪 Berlin, Germany