E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070496 |
E.1.2 | Term | Hemodialysis complication |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066622 |
E.1.2 | Term | Chronic hemodialysis |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051753 |
E.1.2 | Term | Vascular calcification |
E.1.2 | System Organ Class | 10047065 - Vascular disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Attenuation of the progression of coronary and aortic calcification |
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E.2.2 | Secondary objectives of the trial |
Reduction of mortality
Reduction of major cardiovascular adverse events (MACE) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Aortic calcification (volume score)
- Coronary artery calcification (volume score) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
+0, +12, +18 months based on start of vitamin k supplementation |
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E.5.2 | Secondary end point(s) |
- Aortic calcification (Agatston score)
- Coronary artery calcification (Agatston score)
- Calcification of aortic valve
- Calcification of mitral valve
- Major adverse cardiovascular events
- Mortality |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
+0, +12, +18 months based on start of vitamin k supplementation |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard treatment (usual care) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The date of the last telephone interview of the last patient is defined as
the end of the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |