Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Vascular Calcification Systemic and Arterial Stiffness Complication of Hemodialysis Deficiency of Vitamin K2 Drug: menaquinone-7 Phase 2

Layout table for study information
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

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione

Arm Intervention/treatment
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
Drug: menaquinone-7
Oral supplement given post dialysis 3x/week

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



Primary Outcome Measures :
  1. Absolute difference in coronary artery calcium score at 18-month between control and intervention arms [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Health System, Singapore
National Medical Research Council (NMRC), Singapore
Nattopharma ASA
Investigators
Layout table for investigator information
Principal Investigator: Sabrina Wong Peixin Haroon, MD MRCP FAMS National University Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
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