Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients (iPACKHD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor:
Collaborator:
Kingston General Hospital
Information provided by (Responsible Party):
Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT01528800
First received: February 6, 2012
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to see if vitamin K supplementation three times per week reduces the progression of coronary artery calcification over 12 months in dialysis patients compared to placebo?


Condition Intervention Phase
Endstage Kidney Disease
Drug: Vitamin K1
Drug: Chrystalline Lactose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialyis Patients: iPACKHD Study

Resource links provided by NLM:


Further study details as provided by Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • Feasibility of recruiting pts to trial/compliance of study intervention over 12 months & drop out rate of study pts/adherence to study protocol/pilot electronic data capture system/logistics of future multi site RCT [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biomarkers of vitamin K [ Time Frame: baseline; M4; M8; 12 months ] [ Designated as safety issue: No ]
  • cardiovascular events [ Time Frame: monthly assessed ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • coronary artery calcification [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Chrystalline Lactose
Drug: Chrystalline Lactose
10mg orally three times a week for 12 months
Active Comparator: Vitamin K1
Vitamin K1
Drug: Vitamin K1
10mg orally three times a week for 12 months
Other Name: phytonadione

Detailed Description:

At every stage of chronic kidney disease (CKD), the leading cause of mortality is cardiovascular disease. This is due, in part, to vascular calcification of the coronary arteries. The extent of VC in the coronary arteries of patients with CKD is commonly determined by high resolution CT scan. The total coronary artery calcium (CAC) score, measured in Agatston units (AUs), reflects the calcium burden in the 3 major coronary arteries and is the current standard for determining extent of vascular calcification in hemodialysis patients. Matrix Gla protein (MGP), a vitamin K dependent protein, is a key inhibitor of vascular calcification and is present in the arterial wall. It is established that MGP becomes up-regulated adjacent to sites of calcification and that vitamin K is critical to its function. Therefore vitamin K status may be critical to the extent of vascular calcification in this patient group. However, to date, no trial has examined whether vitamin K supplementation prevents the progression of coronary artery calcification in patients with kidney failure, a group in which high risk has been established. Therefore, our primary research question is: Does vitamin K supplementation with 10 mg of phylloquinone thrice weekly reduce the progression of coronary artery calcification (as measured by CAC score) over 12 months in incident hemodialysis patients with a baseline CAC score of >= 30 Agatston Units compared to placebo? Secondary questions include: 1) Does phylloquinone reduce the progression of calcification in the thoracic aorta, aortic valve and mitral valve? and 2) Does phylloquinone decrease major cardiovascular events such as acute coronary syndrome, congestive heart failure, stroke, transient ischemic attack, amputation or revascularization procedure?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have end stage kidney disease and are new to hemodialysis (< 6 months)
  • >=18 years
  • have a baseline coronary artery calcification score >=30AUs
  • are expected to survive one year
  • are able to provide signed informed consent

Exclusion Criteria:

  • have a medical condition that requires warfarin
  • require hemodialysis for acute kidney injury
  • are pregnant
  • have other severe co-morbid conditions (e.g. malignancy, disabling stroke) with life expectancy less than one year
  • have undergone coronary artery bypass grafting or have stents placed in their coronary arteries
  • are currently enrolled in another interventional trial
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528800

Contacts
Contact: Rachel Holden 613-533-3134 holdenr@kgh.kari.net

Locations
Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Rachel Holden         
Sponsors and Collaborators
Dr. Rachel Holden
Kingston General Hospital
Investigators
Principal Investigator: Rachel Holden Queens University or KGH
  More Information

No publications provided

Responsible Party: Dr. Rachel Holden, Assistant Professor of Medicine, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01528800     History of Changes
Other Study ID Numbers: iPACKHD
Study First Received: February 6, 2012
Last Updated: October 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Clinical Evaluation Research Unit at Kingston General Hospital:
Vitamin K
Chronic kidney disease
vascular calcification
hemodialysis
coronary artery calcification

Additional relevant MeSH terms:
Arteriosclerosis
Calcinosis
Coronary Artery Disease
Kidney Diseases
Kidney Failure, Chronic
Arterial Occlusive Diseases
Calcium Metabolism Disorders
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Vascular Diseases
Vitamin K
Vitamin K 1
Vitamins
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014