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| Name | Class |
|---|---|
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
| Nattopharma ASA | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin K2 | Experimental | Vitamin K comes in various isoforms and we have elected to use the K2 isoform - menaquinone-7. We have chosen a dose of 360mcg 3x/week as previous studies using menaquinone-7 demonstrated an increasing dose efficacy relationship up to this strength. Vitamin K2 is manufactured by Nattopharma |
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| Standard Therapy | No Intervention | Subjects randomised to standard therapy will continue to receive dialysis and chronic kidney disease-metabolic bone disease (CKD-MBD) management in accordance to current best practise guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| menaquinone-7 | Drug | Oral supplement given post dialysis 3x/week |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Percentage of patients with regression of CAC of ≥ 10% over 18-month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabrina Wong Peixin Haroon, MD MRCP FAMS | National University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32899022 | Derived | Haroon SW, Tai BC, Ling LH, Teo L, Davenport A, Schurgers L, Teo BW, Khatri P, Ong CC, Low S, Yeo XE, Tan JN, Subramanian S, Chua HR, Tan SY, Wong WK, Lau TW. Treatment to reduce vascular calcification in hemodialysis patients using vitamin K (Trevasc-HDK): A study protocol for a randomized controlled trial. Medicine (Baltimore). 2020 Sep 4;99(36):e21906. doi: 10.1097/MD.0000000000021906. |
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Data to be shared with collaborators
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| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C062629 | menaquinone 7 |
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| 18 months |
| Absolute difference in cfPWV and AI at 18-months | 18 months |
| Mortality from any cause within the study period | 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 | 18 months |
| Difference in plasma levels of dp-ucMGP at 18 months | 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 | 18 months |