A Phase 2 interventional study of menaquinone-7 in Vascular Calcification, Systemic and Arterial Stiffness and Complication of Hemodialysis, sponsored by National University Health System, Singapore. Completed at 1 site in Singapore. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-17.
Sponsored by National University Health System, Singapore · Phase 2, Interventional, and Treatment
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's enrollment of 178 is above the median of 64 across 56 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →National University Health System, Singapore is the lead sponsor of 42 studies on the registry; 13 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
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Contraception
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: menaquinone-7
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
Oral supplement given post dialysis 3x/week
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.
Time frame: 18 months
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.
Time frame: 18 months
Percentage of patients with regression of CAC of ≥ 10% over 18-month
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
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
Difference in plasma levels of dp-ucMGP at 18 months
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
Plan to share: Yes — Data to be shared with collaborators
Ran from Jul 2016 to primary completion in Feb 2022, 67 months.
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Menaquinone 7
National University Health System, Singapore