Vascular CalcificationPhase 2TReVasc-HDKNCT02870829
Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
A Phase 2 study testing menaquinone-7 in people with Vascular Calcification and Systemic and Arterial Stiffness, run by National University Health System, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Vascular Calcification, Systemic and Arterial Stiffness, Complication of Hemodialysis
- What is being tested?
- menaquinone-7
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2016to Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial
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.
- Conditions
- Vascular Calcification, Systemic and Arterial Stiffness, Complication of Hemodialysis, Deficiency of Vitamin K2
- Being tested
- menaquinone-7
- Medical subject headings
- Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
menaquinone-7Drug
Oral supplement given post dialysis 3x/week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: menaquinone-7 |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (7)
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.
Measured: 18 months
Percentage of patients with regression of CAC of ≥ 10% over 18-month
Measured: 18 months
Absolute difference in cfPWV and AI at 18-months
Measured: 18 months
Mortality from any cause within the study period
Measured: 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
Measured: 18 months
Difference in plasma levels of dp-ucMGP at 18 months
Measured: 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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2022
- Study completionFeb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular CalcificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Health System, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Nattopharma ASA
- Responsible party
- Principal investigator, Sabrina Haroon Wong Peixin, National University Health System, Singapore
- Investigators
- Sabrina Wong Peixin Haroon, MD MRCP FAMS, Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870829
- Sponsor's protocol ID
- NHG DSRB Ref: 2015/01000
- Acronym
- TReVasc-HDK
- Status last verified
- Jan 2023
- First submitted
- 14 Aug 2016
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data to be shared with collaborators
Publications
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.
PubMed 32899022
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02870829
- Acronym / sponsor ID
- TReVasc-HDK / NHG DSRB Ref: 2015/01000
- Conditions
- Vascular Calcification, Systemic and Arterial Stiffness, Complication of Hemodialysis, Deficiency of Vitamin K2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- National University Health System, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, Nattopharma ASA
- Study start
- Jul 2016 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2022 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K2 | Experimental | Drug: menaquinone-7Vitamin 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 |
| 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 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| menaquinone-7Oral supplement given post dialysis 3x/week | Drug | Vitamin K2 |
Primary outcome
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.
7 secondary outcomes
Absolute difference in AVC score at 18-months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Derived from this study: PubMed 32899022Haroon 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.
- Individual participant dataSharing planned: Yes. Data to be shared with collaborators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina Wong Peixin Haroon, MD MRCP FAMS principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing menaquinone-7 in people with Vascular Calcification and Systemic and Arterial Stiffness, run by National University Health System, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute difference in coronary artery calcium score at 18-month between control and intervention arms (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02870829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.