Research to (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism
- Conditions
- paricalcitolNLParicalcitolsecondary hyperparathyroidismNLSecundaire hyperparathyreoidievitamin DNLVitamine Dchronic renal diseaseNLChronische nierinsufficientie
- Registration Number
- NL-OMON24070
- Lead Sponsor
- Het Sint Lucas Andreas ziekenhuis
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 114
Inclusion Criteria
1. Hemodialysis patients older than 18 years
2. Secondary hyperparathyroidism
Exclusion Criteria
1. Severe hypercalcemia (Ca2+ >2,65 mmol/L)
2. Severe liver failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness: mean PTH level<br><br>
- Secondary Outcome Measures
Name Time Method - Safety<br /><br>- Mean Calcium (Ca2+)-level<br /><br>- Mean Phosphate (P)-level<br /><br>- Mean Calcium-phosphate (Ca x P) product <br /><br>- Incidences of hypercalcemia <br /><br>- Incidences of hyperphosphatemia<br /><br>- Number of elevated Ca x P <br /><br>- Bone-alkaline phosphatase (BAP), expressed as Z-score<br><br /><br>- Costs<br /><br>- Medication costs of the vitamine D therapy. <br /><br>- Included in the therapy are phosphate binders,<br> calcimimetics, (darbe)poetine and ferric oxide<br><br>