Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

Vascular Calcification Clinical Trial

— TReVasc-HDK  

Official title:

Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870829
• Other study ID #: NHG DSRB Ref: 2015/01000
• Status: Completed
• Phase: Phase 2
• Start date: July 2016
• Est. completion date: February 2022

Study information

• Verified date: January 2023
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population. It will also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of vascular calcification in this group of patients.

This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular events (MACE) over the same period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Complication of Hemodialysis
• Deficiency of Vitamin K2
• Systemic and Arterial Stiffness
• Vascular Calcification
• Vitamin K Deficiency

Intervention

Drug:
• menaquinone-7
Oral supplement given post dialysis 3x/week

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University Health System, Singapore	National Medical Research Council (NMRC), Singapore, Nattopharma ASA

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute difference in coronary artery calcium score at 18-month between control and intervention arms	Comparison made using the t-test following log transformation. Adjustment for baseline CAC scores made via the analysis of covariance.	18 months
Secondary	Absolute difference in AVC score at 18-months	Comparison made using the t-test following log transformation. Adjustment for baseline AVC scores made via the analysis of covariance.	18 months
Secondary	Percentage of patients with regression of CAC of = 10% over 18-month		18 months
Secondary	Absolute difference in cfPWV and AI at 18-months		18 months
Secondary	Mortality from any cause within the study period		18 months
Secondary	MACE defined as non-fatal myocardial infarction, heart failure, acute coronary syndrome, need for coronary revascularization, non-fatal stroke, significant peripheral vascular disease		18 months
Secondary	Difference in plasma levels of dp-ucMGP at 18 months		18 months
Secondary	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		18 months