Clinical Trials Logo
  1. Home
  2. End-Stage Kidney Disease
  3. NCT01528800

Vitamin K to Attenuate Coronary Artery Calcification in Hemodialysis Patients — iPACK-HD  

End-stage Kidney Disease Clinical Trial

Official title:
Inhibit Progression of Coronary Artery Calcification With Vitamin K in HemoDialysis Patients: The iPACK-HD Study

Clinical Trial 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.

Clinical Trial 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 (VC) 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 three 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 prevalent hemodialysis patients with a baseline CAC score of ≥ 30 Agatston Units compared to placebo? ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01528800
Study type Interventional
Source Clinical Evaluation Research Unit at Kingston General Hospital
Contact
Status Completed
Phase Phase 2
Start date November 2012
Completion date December 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Active, not recruiting NCT05027074 - Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) Phase 2
Completed NCT03582592 - Fluid Distribution Timetable on Adherence to Fluid Restriction of Patients With End-Stage Renal Disease on Hemodialysis N/A
Completed NCT02694068 - Biological Determinants of Peritoneal Dialysis
Not yet recruiting NCT02832505 - Applications of MRI in Kidney Disease
Not yet recruiting NCT02590081 - Effect of Sodium Rinsing Fluid on Blood Pressure and Interdialytic Weight Change in Hemodialysis Patients Phase 4
Completed NCT01859884 - Optimizing Kidney Transplant Informed Consent N/A
Completed NCT00509236 - Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and End-Stage Renal Disease (MK-0431-073 AM1) Phase 3
Completed NCT02009514 - Glucose Containing and Glucose Free Hemodialysate in Type 2 Diabetic Patients Phase 4
Not yet recruiting NCT06377293 - Effect of Dialysis-specific Therapeutic Diet on Biochemical Parameters in Dialysis Patients N/A
Completed NCT01863914 - Vascular Protective Effect of Rosuvastatin in Arteriovenous Fistula Phase 2
Withdrawn NCT06030050 - Animal Assisted Intervention for Hemodialysis Outpatients N/A
Completed NCT04610593 - Effects of a Mindfulness-based Intervention in Stress, Pain and Quality of Life in People Undergoing Hemodialysis N/A
Recruiting NCT05931276 - CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes Phase 3
Completed NCT00143741 - Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers Phase 1
Active, not recruiting NCT02755610 - Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis N/A
Recruiting NCT03142529 - Traditional Chinese Medicine (TCM) Colon Dialysis Treats Non-dialysis End-Stage Kidney Disease Phase 1/Phase 2
Completed NCT02342119 - Increasing Equity in Transplant Evaluation and Living Donor Kidney Transplantation N/A
Recruiting NCT05614115 - Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD Phase 1
Recruiting NCT01111422 - Anti-Oxidant Effect on Peritoneal Membrane in Peritoneal Dialysis (PD) Patients Phase 4