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Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (TReVasc-HDK)

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ClinicalTrials.gov Identifier: NCT02870829
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : July 22, 2020
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
Nattopharma ASA
Information provided by (Responsible Party):
Sabrina Haroon Wong Peixin, National University Health System, Singapore

Tracking Information
First Submitted Date  ICMJE August 14, 2016
First Posted Date  ICMJE August 17, 2016
Last Update Posted Date July 22, 2020
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
Absolute difference in coronary artery calcium score at 18-month between control and intervention arms [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2016)
Absolute difference in CAC score at 18-month between control and intervention arms [ Time Frame: 18 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
Official Title  ICMJE Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K (Trevasc-HDK): A Study Protocol for a Randomized Controlled Trial
Brief 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.

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vascular Calcification
  • Systemic and Arterial Stiffness
  • Complication of Hemodialysis
  • Deficiency of Vitamin K2
Intervention  ICMJE Drug: menaquinone-7
Oral supplement given post dialysis 3x/week
Study Arms  ICMJE
  • 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
    Intervention: Drug: menaquinone-7
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 2, 2017)
178
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2016)
200
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of thrombosis in the last 6 months except vascular access thrombosis
  2. Need for vitamin K antagonists therapy at baseline or in the 3 months prior to baseline
  3. Presence of significant gut disease (inflammatory bowel disease, short-bowel syndrome)
  4. Liver dysfunction
  5. Alcohol or drug abuse
  6. Presence of coronary stent or have undergone coronary artery bypass grafting
  7. Women who are pregnant or breast feeding,
  8. Those who are fearful of confined space and cannot lie still for Multislice Computed Tomography
  9. Lack of safe contraceptive measures.
  10. Those who had parathyroid surgery done.
  11. Those with parathyroid hormone (PTH) > 150 pmol/l
  12. Patient taking multivitamins containing vitamin K
  13. Patient allergic to soy based products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02870829
Other Study ID Numbers  ICMJE NHG DSRB Ref: 2015/01000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data to be shared with collaborators
Responsible Party Sabrina Haroon Wong Peixin, National University Health System, Singapore
Study Sponsor  ICMJE National University Health System, Singapore
Collaborators  ICMJE
  • National Medical Research Council (NMRC), Singapore
  • Nattopharma ASA
Investigators  ICMJE
Principal Investigator: Sabrina Wong Peixin Haroon, MD MRCP FAMS National University Health System
PRS Account National University Health System, Singapore
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP