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

This study is currently recruiting participants.
Verified July 2017 by Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01528800
First Posted: February 8, 2012
Last Update Posted: July 25, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Kingston General Hospital
Information provided by (Responsible Party):
Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital
February 6, 2012
February 8, 2012
July 25, 2017
November 2012
October 2018   (Final data collection date for primary outcome measure)
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 ]
  • Feasibility of recruiting pts to trial [ Time Frame: 12 months ]
  • compliance with study intervention over 6 months [ Time Frame: 12 months ]
  • drop-out rate of study patients [ Time Frame: 12 months ]
  • adherence to study protocol [ Time Frame: 12 months ]
  • pilot electronic data capture system [ Time Frame: 12 months ]
  • determine logistics of future multi-center trial [ Time Frame: 12 months ]
Complete list of historical versions of study NCT01528800 on ClinicalTrials.gov Archive Site
  • biomarkers of vitamin K [ Time Frame: baseline; M4; M8; 12 months ]
  • cardiovascular events [ Time Frame: monthly assessed ]
  • mortality [ Time Frame: 12 months ]
  • coronary artery calcification [ Time Frame: 12 months ]
  • biomarkers of vitamin K [ Time Frame: baseline and 6 months ]
  • cadiovascular events [ Time Frame: monthly assessed ]
  • mortality [ Time Frame: 6 months ]
  • coronary artery calcification [ Time Frame: 6 months ]
Not Provided
Not Provided
 
Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients
Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialyis Patients: iPACKHD Study
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?
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?
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Endstage Kidney Disease
  • Drug: Vitamin K1
    10mg orally three times a week for 12 months
    Other Name: phytonadione
  • Drug: Chrystalline Lactose
    10mg orally three times a week for 12 months
  • Placebo Comparator: Placebo
    Chrystalline Lactose
    Intervention: Drug: Chrystalline Lactose
  • Active Comparator: Vitamin K1
    Vitamin K1
    Intervention: Drug: Vitamin K1
Holden RM, Booth SL, Day AG, Clase CM, Zimmerman D, Moist L, Shea MK, McCabe KM, Jamal SA, Tobe S, Weinstein J, Madhumathi R, Adams MA, Heyland DK. Inhibiting the progression of arterial calcification with vitamin K in HemoDialysis patients (iPACK-HD) trial: rationale and study design for a randomized trial of vitamin K in patients with end stage kidney disease. Can J Kidney Health Dis. 2015 May 1;2:17. doi: 10.1186/s40697-015-0053-x. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2018
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Rachel Holden 613-533-3134 holdenr@kgh.kari.net
Canada
 
 
NCT01528800
iPACKHD
No
Not Provided
Not Provided
Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital
Dr. Rachel Holden
Kingston General Hospital
Principal Investigator: Rachel Holden Queens University or KGH
Clinical Evaluation Research Unit at Kingston General Hospital
July 2017

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