Placebo-gecontroleerde dubbelblinde gerandomiseerde gecontroleerde studie naar vitamine K-suppletie op vasculaire calcificatie-neiging bij niertransplantatiepatiënten met vitamine K-deficiëntie
Recruiting
- Conditions
- Renal transplant recipients with vitamin K deficiency
- Registration Number
- NL-OMON23704
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Age =18 years
2. Male and female renal transplant recipients
3. Participant of TransplantLines
4. Vitamin K deficient; dp-ucMGP >500 pmol/L
5. eGFR > 20 ml/min/1.73m2
6. Signed informed consent
Exclusion Criteria
1. Treatment with vitamin K antagonists or direct oral anticoagulants (DOAC)
2. Atrial fibrillation
3. Known coagulopathy
4. Active malignancy; exception treated basal cell or squamous cell carcinoma
5. Current or planned pregnancy or lactation
6. Known intestinal malabsorption
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is change from baseline in serum calcification propensity at 12 weeks following intervention.
- Secondary Outcome Measures
Name Time Method Secondary endpoints includes change from baseline in parameters of vitamin K status (e.g., dp-ucMGP) and vascular stiffness (i.e., pulse wave velocity).