No registrations found.
ID
Source
Brief title
Health condition
Chronic Renal Failure: chronisch nierfalen
Secondary Hyperparathyroidism: secundaire hyperparathyreoidie
Vitamin D: vitamine D
Paricalcitol: paricalcitol
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness: measure the main PTH level
Secondary outcome
Security
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.
Background summary
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
Study objective
Paricalcitol induce a more effective reduction of the PTH level compared to alfacalcidol at hemodialysispatients with secondary hyperparathyroidism
Study design
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
Intervention
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.
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
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
Inclusion criteria
1. Hemodialysis patients older than 18 years
2. Secundary hyperparathyroidism
Exclusion criteria
1. Severe hypercalcemia
2. Severe liver failure
3. Digoxin overdose
4. Hypersensitive response to vitamin D or vitamin D overdose
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1294 |
| NTR-old | NTR1341 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |