Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients (iPACK HD)
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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: iPACK HD Study |
- 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 ]
- biomarkers of vitamin K [ Time Frame: baseline and 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: | May 2015 |
| Estimated Primary Completion Date: | November 2014 (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 |
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 sever 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| Contact: Rachel Holden | 613-533-3134 | holdenr@kgh.kari.net |
| Canada, Ontario | |
| Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Principal Investigator: Rachel Holden | |
| 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: | iPACK HD |
| Study First Received: | February 6, 2012 |
| Last Updated: | March 5, 2013 |
| 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:
|
Calcinosis Kidney Diseases Kidney Failure, Chronic Coronary Artery Disease Arteriosclerosis Calcium Metabolism Disorders Metabolic Diseases Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arterial Occlusive Diseases |
Vascular Diseases Vitamin K 1 Vitamin K Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013