Vitamin K1 to slow vascular calcification in hemodialysis patients

Phase 1

• Conditions: MedDRA version: 19.1Level: LLTClassification code 10070496Term: Hemodialysis complicationSystem Organ Class: 100000004863; MedDRA version: 19.1Level: LLTClassification code 10066622Term: Chronic hemodialysisSystem Organ Class: 100000004865; MedDRA version: 19.1Level: PTClassification code 10051753Term: Vascular calcificationSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-021264-14-BE
• Lead Sponsor: RWTH Aachen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-07
• Last Update Posted: 25 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

- Male or female = 18 years of age
- Not less than 6 months on hemodialysis
- Calcification score > 100
- Written consent to take part in the study
- Expectation of life not less than 18 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 234

Exclusion Criteria

- Known hypersensitivity against vitamin K1
- Intake of Vitamin K
- History of thrombosis (except shunt occlusion)
- Intake of Vitamin K antagonists (e.g. Marcumar®)
- Inflammatory bowel disease
- tumor disease
- Short-bowel-syndrome
- Liver dysfunction
- anemia (Hb < 70 g/l)
- More than one stent in one coronary artery plus one or more stents in an additional artery
- Pulse > 100/min (resting heart rate)
- Women who are pregnant or breastfeeding
- Women without sufficient contraception
- Alcohol or drug abuse
- Mental condition rendering the subject unable to understand the
nature, scope, and possible consequences of the study
- Subject unlikely to comply with protocol, e.g. uncooperative attitude,inability to return for follow-up-visits, and unlikelihood of completing the
study
- Participation in a parallel clinical trial or participation in another
clinical trial within the last 3 months
- Subjects who are in any state of dependency to the sponsor or the
investigators
- Employees of the sponsor or the investigators
- Subjects who have been committed to an institution by legal or
regulatory order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Attenuation of the progression of coronary and aortic calcification;Secondary Objective: Reduction of mortality<br>Reduction of major cardiovascular adverse events (MACE);Primary end point(s): - Aortic calcification (volume score)<br>- Coronary artery calcification (volume score);Timepoint(s) of evaluation of this end point: +0, +12, +18 months based on start of vitamin k supplementation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Aortic calcification (Agatston score)<br>- Coronary artery calcification (Agatston score)<br>- Calcification of aortic valve<br>- Calcification of mitral valve<br>- Major adverse cardiovascular events<br>- Mortality;Timepoint(s) of evaluation of this end point: +0, +12, +18 months based on start of vitamin k supplementation