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Research to cost-effectiveness of paricalcitol of the treatment of secundary hyperparathyroidism at hemodialysis patients


- candidate number3460
- NTR NumberNTR1341
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2008
- Secondary IDs 
- Public TitleResearch to cost-effectiveness of paricalcitol of the treatment of secundary hyperparathyroidism at hemodialysis patients
- Scientific TitleResearch to cost-effectiveness of paricalcitol of the treatment of secundary hyperparathyroidism at hemodialysispatients
- ACRONYMKEPS
- hypothesisParicalcitol induce a more effective reduction of the PTH level compared to alfacalcidol at hemodialysispatients with secondary hyperparathyroidism
- Healt Condition(s) or Problem(s) studiedChronic renal failure, Secondary hyperparathyroidism, Vitamin D, Paricalcitol
- Inclusion criteria1. Hemodialysis patients older than 18 years
2. Secundary hyperparathyroidism
- Exclusion criteria1. Severe hypercalcemia
2. Severe liver failure
3. Digoxin overdose
4. Hypersensitive response to vitamin D or vitamin D overdose
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2008
- planned closingdate1-jan-2010
- Target number of participants114
- InterventionsAfter randomisation two groups of hemodialysispatients will be separated.
Group A gets treated with alfacalcitol and Group B with paricalcitol.
After six months will the groups switch.
- Primary outcomeEffectiveness: measure the main PTH level
- Secondary outcomeSecurity
Main Calcium (Ca2+)-level
Main Fosfaat (P)-level
Main Calicum-Fosfaatproduct (Ca x P) -level
Numbers of hypercalcemia episodes
Numbers of hyperphosphatemia episodes
Numbers of raised Ca x P episodes
Bone-alkaline phosphatase (BAP), expressed as a Z-score


Costs
Total costs of the whole treatment:
measuring the oral medication of phosphate-binders and calcimimetics.
- TimepointsPTH: Every 4 weeks inclusive the Baseline
Ca 2+ tot: Every 2 weeks inclusive the Baseline
Ca2+ ion: Every 2 weeks inclusive the Baseline
Alb serum: Every 2 weeks inclusive the Baseline
P: Every 2 weeks inclusive the Baseline
Ca2+ x P: Every 2 weeks inclusive the Baseline
Bone-AP: Baseline, month 6, month 12
Hb: Every 4 weeks
Ferritine: Every 4 weeks
Urea (BUN): Baseline, month 6, month 12
Creat: Baseline, month 6, month 12
CRP: Baseline, month 6, month 12
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Joris J.G Heuvel, van den
- CONTACT for SCIENTIFIC QUERIES Joris J.G Heuvel, van den
- Sponsor/Initiator Sint Lucas Andreas Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Sint Lucas Andreas Ziekenhuis
- PublicationsN/A
- Brief summaryThe inadequate treatment of secondary hyperparathyroidism can have severe consequences, for example hyperplastic parathyroid glands, renal osteodystrophy and cardiovascular dis-eases.
Paricalcitol (Zemplar®) is a recently introduced third generation vitamin D analogon. The treatment with paricalcitol could have several advantages to the treatment with the “old” vi-tamin D analogon: alfacalcidol (Etalpha®).
Paricalcitol should correct the parathormone (PTH) level faster and reduce the numbers of hypercalcemia episodes. The trial is limited and the database on this subject is small, so the question if paricalcitol is more effective than the “old” vitamin D analoga alfacalcidol and calcitriol is relevant. This trial compares paricalcitol with alfacalcidol, the most used vitamin D in the Netherlands. The treatment with paricalcitol is four times more expensive that the treatment with alfacalcidol. The trial that compares the effectiveness, security and the costs between paricalcitol and alfacalcidol will give a useful insight to optimize the treatment for hemodialysispatients with secondary hyperparathyroidism
- Main changes (audit trail)
- RECORD11-jun-2008 - 25-jul-2008


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