Paricalcitol induce a more effective reduction of the PTH level compared to alfacalcidol at hemodialysispatients with secondary hyperparathyroidism
ID
Bron
Verkorte titel
Aandoening
Chronic Renal Failure: chronisch nierfalen
Secondary Hyperparathyroidism: secundaire hyperparathyreoidie
Vitamin D: vitamine D
Paricalcitol: paricalcitol
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Effectiveness: measure the main PTH level
Achtergrond van het onderzoek
The 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
Doel van het onderzoek
Paricalcitol induce a more effective reduction of the PTH level compared to alfacalcidol at hemodialysispatients with secondary hyperparathyroidism
Onderzoeksopzet
PTH: 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
Onderzoeksproduct en/of interventie
After 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.
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. Secundary hyperparathyroidism
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Severe hypercalcemia
2. Severe liver failure
3. Digoxin overdose
4. Hypersensitive response to vitamin D or vitamin D overdose
Opzet
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