NCT03104166: ModuVas

Modulation of Vascular Calcification in Chronic Dialysis Patients

Completed NA Last updated 23 January 2020

What this trial tests

NA trial testing Medium Cut-Off (MCO) dialysis membrane in Vascular Calcification in 50 participants. Completed in 31 August 2019.

Timeline

22 January 2018

Primary endpoint
30 August 2019

31 August 2019

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	22 January 2018
Primary completion	30 August 2019
Estimated completion	31 August 2019
Sites	1 location across Germany

Drugs / interventions tested

• Medium Cut-Off (MCO) dialysis membrane
• High-Flux dialysis membrane

Conditions studied

• Vascular Calcification — all drugs for Vascular Calcification →

Sponsor

Charite University, Berlin, Germany

Who can join

18 and older, any sex, with Vascular Calcification. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phosphate, Calcification in Blood, and Mineral Stress: The Physiologic Blood Mineral Buffering System and Its Association with Cardiovascular Risk.
   Pasch A, Jahnen-Dechent W, Smith ER. · · 2018 · cited 34× · PMID 30245880 · DOI 10.1155/2018/9182078
2. Vascular calcification: from the perspective of crosstalk.
   Yang S, Zeng Z, Yuan Q, Chen Q, et al · · 2023 · cited 13× · PMID 37851172 · DOI 10.1186/s43556-023-00146-y