Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

• Register: ClinicalTrials.gov
• Last refreshed on: 23 January 2023
• Main ID: NCT02870829
• Date of registration: 14/08/2016
• Prospective Registration: No
• Primary sponsor: National University Health System, Singapore
• Public title: Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K TReVasc-HDK
• Scientific title: Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial
• Date of first enrolment: July 2016
• Target sample size: 178
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02870829
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Singapore

Contacts

• Name: Sabrina Wong Peixin Haroon, MD MRCP FAMS
• Affiliation: National University Health System

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age = 45 years and less than 80 years

2. At least 12 months on Hemodialysis

3. Coronary artery calcium score of = 30 in the baseline Multislice Computed Tomography

4. Able to give informed consent

5. Life expectancy of at least18 months

Exclusion Criteria:

1. History of thrombosis in the last 6 months except vascular access thrombosis

2. Need for vitamin K antagonists therapy at baseline or in the 3 months prior to
baseline

3. Presence of significant gut disease (inflammatory bowel disease, short-bowel syndrome)

4. Liver dysfunction

5. Alcohol or drug abuse

6. Presence of coronary stent or have undergone coronary artery bypass grafting

7. Women who are pregnant or breast feeding,

8. Those who are fearful of confined space and cannot lie still for Multislice Computed
Tomography

9. Lack of safe contraceptive measures.

10. Those who had parathyroid surgery done.

11. Those with parathyroid hormone (PTH) > 150 pmol/l

12. Patient taking multivitamins containing vitamin K

13. Patient allergic to soy based products



Age minimum: 21 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Deficiency of Vitamin K2

Systemic and Arterial Stiffness

Vascular Calcification

Complication of Hemodialysis

Intervention(s)

Drug: menaquinone-7

Primary Outcome(s)

Absolute difference in coronary artery calcium score at 18-month between control and intervention arms [Time Frame: 18 months]

Secondary Outcome(s)

Absolute difference in AVC score at 18-months [Time Frame: 18 months]

MACE defined as non-fatal myocardial infarction, heart failure, acute coronary syndrome, need for coronary revascularization, non-fatal stroke, significant peripheral vascular disease [Time Frame: 18 months]

Vascular access events, including clotting requiring insertion of a new dialysis catheter, declotting or exchange of an existing catheter, and vascular intervention during the study period [Time Frame: 18 months]

Difference in plasma levels of dp-ucMGP at 18 months [Time Frame: 18 months]

Absolute difference in cfPWV and AI at 18-months [Time Frame: 18 months]

Mortality from any cause within the study period [Time Frame: 18 months]

Percentage of patients with regression of CAC of = 10% over 18-month [Time Frame: 18 months]

Secondary ID(s)

NHG DSRB Ref: 2015/01000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Medical Research Council (NMRC), Singapore

Nattopharma ASA