Vascular calcification in renal TransplantLines
Completed
- Conditions
- niertransplantatievascular calcification1001108210013296
- Registration Number
- NL-OMON46743
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
Inclusion Criteria
1. Age >=18 years
2. Male and female renal transplant recipients
3. Participant of TransplantLines
4. 6-12 months post kidney transplantation
5. eGFR > 30 ml/min/1.73m2
6. Signed informed consent
Exclusion Criteria
1. Life-expectancy < 2 years
2. Active malignancy; exception treated basal cell or squamous cell carcinoma
3. Known pregnancy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the association between baseline serum<br /><br>calcification propensity and the relative change in the CAC score over a<br /><br>two-year period.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To identify endogenous and exogenous determinants of CAC-score (progression)<br /><br>and calcification propensity information on age, sex, medical history, duration<br /><br>of pre transplantation dialysis, lifestyle factors including detailed nutrition<br /><br>data and physical activity, use of medication, physical data (including blood<br /><br>pressure and body mass index), and biochemical data, including blood and 24-h<br /><br>urine samples will be collected as part of routine TransplantLines procedures.<br /><br>From the samples collected and stored by TransplantLines, we will analyse<br /><br>parameters of vitamin K status (e.g., nonphosphorylated-uncarboxylated [dp-uc]<br /><br>MGP), parameters of mineral metabolism (i.e., serum phosphate, calcium,<br /><br>albumin, magnesium, PTH, and FGF23), lipid profile, renal function and albumin<br /><br>excretion/24h.</p><br>