Paricalcitol 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…
ID
Bron
Verkorte titel
Aandoening
paricalcitol
NL
Paricalcitol
secondary hyperparathyroidism
NL
Secundaire hyperparathyreoidie
vitamin D
NL
Vitamine D
chronic renal disease
NL
Chronische nierinsufficientie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Effectiveness: mean PTH level
Achtergrond van het onderzoek
An 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.
Doel van het onderzoek
Paricalcitol 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.
Onderzoeksopzet
- 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
Onderzoeksproduct en/of interventie
Hemodialysis patients will be randomized.
Group A gets treated with alfacalcidol and Group B with paricalcitol.
After six months the groups switch.
Publiek
Postbus 9243
1006 AE
Joris J.G Heuvel, van den
Jan Tooropstraat 164
1061 AE
Amsterdam
The Netherlands
+31 (020) 5108911
j.vandenheuvel@slaz.nl
Wetenschappelijk
Postbus 9243
1006 AE
Joris J.G Heuvel, van den
Jan Tooropstraat 164
1061 AE
Amsterdam
The Netherlands
+31 (020) 5108911
j.vandenheuvel@slaz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Hemodialysis patients older than 18 years
2. Secondary hyperparathyroidism
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Severe hypercalcemia (Ca2+ >2,65 mmol/L)
2. Severe liver failure
3. Digoxin overdose
4. Hypersensitivity to vitamin D or vitamin D overdose
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL1309 |
NTR-old | NTR1358 |
CCMO | NL15946.029.07 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
OMON | NL-OMON31628 |