Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
Status:
Active, not recruiting
Trial end date:
2020-11-01
Target enrollment:
Participant gender:
Summary
The proposed study will seek to evaluate the prevalence and the progression of vascular
calcification in a cohort of maintenance hemodialysis patients in Asian population. It will
also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of
vascular calcification in this group of patients.
This will be a single-center randomized, prospective and open-label interventional clinical
trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute
difference in coronary artery calcium (CAC) score at 18-month between control and
intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve
calcification, percentage of patients with regression of coronary artery calcification of at
least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any
cause and major adverse cardiovascular events (MACE) over the same period.
Phase:
Phase 2
Details
Lead Sponsor:
National University Health System, Singapore
Collaborators:
National Medical Research Council (NMRC), Singapore Nattopharma ASA