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Completed

NCT Number: NCT02870829

Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

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.

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Key information

Conditions

Vascular Calcification Calcinosis Calcium Metabolism Disorders Complication of Hemodialysis Deficiency of Vitamin K2 Metabolic Diseases Nutritional and Metabolic Diseases Systemic and Arterial Stiffness

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National University Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 45 years and less than 80 years
  • At least 12 months on Hemodialysis
  • Coronary artery calcium score of ≥ 30 in the baseline Multislice Computed Tomography
  • Able to give informed consent
  • Life expectancy of at least18 months

Exclusion criteria

  • History of thrombosis in the last 6 months except vascular access thrombosis
  • Need for vitamin K antagonists therapy at baseline or in the 3 months prior to baseline
  • Presence of significant gut disease (inflammatory bowel disease, short-bowel syndrome)
  • Liver dysfunction
  • Alcohol or drug abuse
  • Presence of coronary stent or have undergone coronary artery bypass grafting
  • Women who are pregnant or breast feeding,
  • Those who are fearful of confined space and cannot lie still for Multislice Computed Tomography
  • Lack of safe contraceptive measures.
  • Those who had parathyroid surgery done.
  • Those with parathyroid hormone (PTH) > 150 pmol/l
  • Patient taking multivitamins containing vitamin K
  • Patient allergic to soy based products

Treatment and study plan

menaquinone-7

Drug

Oral supplement given post dialysis 3x/week

Primary outcomes

  1. Absolute difference in coronary artery calcium score at 18-month between control and intervention arms

    Time frame: 18 months

    Comparison made using the t-test following log transformation. Adjustment for baseline CAC scores made via the analysis of covariance.

Secondary outcomes

  1. Absolute difference in AVC score at 18-months

    Time frame: 18 months

    Comparison made using the t-test following log transformation. Adjustment for baseline AVC scores made via the analysis of covariance.

  2. Percentage of patients with regression of CAC of ≥ 10% over 18-month

    Time frame: 18 months

  3. Absolute difference in cfPWV and AI at 18-months

    Time frame: 18 months

  4. Mortality from any cause within the study period

    Time frame: 18 months

  5. 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

  6. Difference in plasma levels of dp-ucMGP at 18 months

    Time frame: 18 months

  7. 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

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore
  • Nattopharma ASA

Registry information

Official study title

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

Acronym: TReVasc-HDK

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Aug 17, 2016
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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