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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24822
Enrollment
114
Registered
2008-06-11
Start date
2008-07-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Failure: chronisch nierfalen Secondary Hyperparathyroidism: secundaire hyperparathyreoidie Vitamin D: vitamine D Paricalcitol: paricalcitol

Interventions

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.

Sponsors

Sint Lucas Andreas ziekenhuis
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Hemodialysis patients older than 18 years 2. Secundary hyperparathyroidism

Exclusion criteria

Exclusion criteria: 1. Severe hypercalcemia 2. Severe liver failure 3. Digoxin overdose 4. Hypersensitive response to vitamin D or vitamin D overdose

Design outcomes

Primary

MeasureTime frame
Effectiveness: measure the main PTH level

Secondary

MeasureTime frame
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.

Contacts

Public ContactJoris J.G Heuvel, van den

Sint Lucas Andreas ziekenhuis Postbus 9243 1006 AE

j.vandenheuvel@slaz.nl+31 (020) 5108911

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)