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Research to (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism


- candidate number3530
- NTR NumberNTR1358
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2008
- Secondary IDsNL15946.0239.07 
- Public TitleResearch to (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism
- Scientific TitleResearch to (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism
- ACRONYMKEPS
- hypothesisParicalcitol induces a more effective reduction of the PTH level than alfacalcidol in hemodialysis pa-tients with secondary hyperparathyroidism NL Paricalcitol geeft een effectievere daling van de PTH spiegel ten opzichte van alfacalcidol bij hemodi-alysepatiënten met secundaire hyperparathyreoïdie.
- Healt Condition(s) or Problem(s) studiedRenal insufficiency, Chronic, Secondary hyperparathyroidism, Vitamin D, Paricalcitol
- Inclusion criteria1. Hemodialysis patients older than 18 years
2. Secondary hyperparathyroidism
- Exclusion criteria1. Severe hypercalcemia (Ca2+ >2,65 mmol/L)
2. Severe liver failure
3. Digoxin overdose
4. Hypersensitivity to vitamin D or vitamin D overdose
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-feb-2010
- Target number of participants114
- InterventionsHemodialysis patients will be randomized.
Group A gets treated with alfacalcidol and Group B with paricalcitol.
After six months the groups switch.
- Primary outcomeEffectiveness: mean PTH level
- Secondary outcome- Safety
- Mean Calcium (Ca2+)-level
- Mean Phosphate (P)-level
- Mean Calcium-phosphate (Ca x P) product
- Incidences of hypercalcemia
- Incidences of hyperphosphatemia
- Number of elevated Ca x P
- Bone-alkaline phosphatase (BAP), expressed as Z-score
- Costs
- Medication costs of the vitamine D therapy.
- Included in the therapy are phosphate binders, calcimimetics, (darbe)poetine and ferric oxide
- Timepoints- PTH:
Baseline, every 4 weeks
- Ca 2+ tot:
Baseline, every 2 weeks
- Ca2+ ion:
Baseline, every 2 weeks
- Albumin:
Baseline, every 2 weeks
- P:
Baseline, every 2 weeks
- Ca x P:
Baseline, every 2 weeks
- 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 summaryAn inadequate treatment of secondary hyperparathyroidism can have severe consequences, such as hyperplastic parathyroid glands, renal osteodystrophy and cardiovascular diseases.
Paricalcitol (Zemplar®) is a recently introduced third generation vitamin D analogon.
Paricalcitol is supposed to have several advantages in comparison to the “old” vitamin D alfa-calcidol (Etalpha®). According to several trials, paricalcitol corrects parathormone (PTH) levels faster and reduces the incidences of hypercalcemia. Trials and evidence are limited, so the question if parical-citol is more effective than the “old” vitamin D analoga alfacalcidol and calcitriol remains relevant. This trial compares paricalcitol with alfacalcidol, the most frequently used vitamin D in the Netherlands. Treatment with paricalcitol is four times more expensive that treatment with alfacalcidol. This trial compares effectiveness, safety and costs of paricalcitol and alfa-calcidol. With this trial treatment of secondary hyperparathyroidism in hemodialysis patients can be optimized.
- Main changes (audit trail)
- RECORD25-jun-2008 - 25-jul-2008


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