Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (TReVasc-HDK)
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| ClinicalTrials.gov Identifier: NCT02870829 |
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Recruitment Status :
Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : July 22, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vascular Calcification Systemic and Arterial Stiffness Complication of Hemodialysis Deficiency of Vitamin K2 | Drug: menaquinone-7 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 178 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial |
| Actual Study Start Date : | July 2016 |
| Estimated Primary Completion Date : | October 2020 |
| Estimated Study Completion Date : | November 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin K2
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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Drug: menaquinone-7
Oral supplement given post dialysis 3x/week |
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No Intervention: Standard Therapy
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
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- Absolute difference in coronary artery calcium score at 18-month between control and intervention arms [ Time Frame: 18 months ]
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| Ages Eligible for Study: | 21 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870829
| Singapore | |
| National University Hospital | |
| Singapore, Singapore | |
| Principal Investigator: | Sabrina Wong Peixin Haroon, MD MRCP FAMS | National University Health System |
| Responsible Party: | Sabrina Haroon Wong Peixin, Consultant Nephrologist, University Medicine Cluster, National University Health System, Singapore |
| ClinicalTrials.gov Identifier: | NCT02870829 |
| Other Study ID Numbers: |
NHG DSRB Ref: 2015/01000 |
| First Posted: | August 17, 2016 Key Record Dates |
| Last Update Posted: | July 22, 2020 |
| Last Verified: | July 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data to be shared with collaborators |
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Vitamin K Deficiency Calcinosis Vascular Calcification Calcium Metabolism Disorders Metabolic Diseases Blood Coagulation Disorders Hematologic Diseases Hemorrhagic Disorders Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamin K 2 |
Vitamin K Vitamin MK 7 Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs |