Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients

NCT01528800 | Completed Phase 2

• 1 other identifier: iPACK-HD
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

End-stage Kidney Disease

Keywords

Vitamin K; Chronic Kidney Disease; Vascular Calcification; Hemodialysis; Coronary Artery Calcification

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Number of participants recruited per month at each site) and an overall crude average of each site's rate.

  12 months

• Compliance with study medication

  Proportion of prescribed doses received.

  12 months

• Dropout rate

  Proportion of participants who dropped out from the trial.

  12 months

• Adherence to study protocol

  Proportion of participants who adhered to the study protocol.

  12 months

• Rates of eligible patients consented and randomized

  Proportion of eligible patients consented and randomized.

  12 months

Secondary Outcomes (17)

• Coronary artery calcification (Agatston calcium scores) progression

  12 months

• Coronary artery calcification (volume calcium scores) progression

  12 months

• Coronary artery calcification (Agatston calcium scores) regression

  12 months

• Coronary artery calcification (volume calcium scores) regression

  12 months

• Aortic valve calcification (Agatston calcium scores) progression

  12 months

Other Outcomes (6)

• Levels of biomarkers of inflammation

  12 months

• Levels of clinical lab values

  12 months

• Concomitant medication assessment (presence/absence/dosage)

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Microcrystalline Methylcellulose

Drug: Microcrystalline Methylcellulose

Vitamin K1

ACTIVE COMPARATOR

Vitamin K1

Drug: Vitamin K1

Interventions

Vitamin K1 DRUG

10mg orally three times a week for 12 months

Also known as: Phytonadione, Phylloquinone

Vitamin K1

Microcrystalline Methylcellulose DRUG

10mg orally three times a week for 12 months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide signed informed consent
• ≥18 years of age
• Expected to survive one year
• Have end-stage kidney disease and require hemodialysis
• Have a baseline coronary artery calcification score ≥30 Agatston units (AUs)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Rachel Holden: lead

Study Sites (3)

Kingston Health Sciences Centre: Kingston General Hospital Site

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (2)

• Holden RM, Booth SL, Zimmerman D, Moist L, Norman PA, Day AG, Menard A, Fu X, Shea MK, Babiolakis CS, Nolan R, Turner ME, Ward E, Kaufmann M, Adams MA, Heyland DK. Inhibit progression of coronary artery calcification with vitamin K in hemodialysis patients (the iPACK-HD study): a randomized, placebo-controlled multi-center, pilot trial. Nephrol Dial Transplant. 2023 Feb 28;38(3):746-756. doi: 10.1093/ndt/gfac191.

  PMID: 35641194 DERIVED

• 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.

  PMID: 26075081 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic; Vascular Calcification

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Officials

• Rachel Holden

  Queens University/Kingston Health Sciences Centre: Kingston General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine Queen's University

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 8, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

CA (3)