Research with human participants

Overview of medical research in the Netherlands

The (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism in hemodialysis patients.

Published:
Last updated:

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Parathyroid gland disorders
Study type
Interventional

ID

NL-OMON31628

Source

ToetsingOnline

Brief title

CEPS

Condition

  • Parathyroid gland disorders
  • Nephropathies

Synonym

hyperparathyroidism; increased activity of the parathyroids

Research involving

Human

Sponsors and support

Primary sponsor :
Sint Lucas Andreas Ziekenhuis
Source(s) of monetary or material Support :
Sint Lucas Andreas ziekenhuis

Intervention

Keyword :
chronic renal disease, paricalcitol, secondary hyperparathyroidism, vitamin D

Outcome measures

Primary outcome

.

Secondary outcome

.

Background summary

.

Study objective

.

Study design

.

Intervention

.

Study burden and risks

.

Public
Sint Lucas Andreas Ziekenhuis

Jan Tooropstraat 164
1061AE Amsterdam
NL
Scientific
Sint Lucas Andreas Ziekenhuis

Jan Tooropstraat 164
1061AE Amsterdam
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- Hemodialysis patient > 18 years
- Secondary hyperparathyoidism

Exclusion criteria

- Severe hypercalcemia (Ca2+ > 2,65 mmol/L)
- Severe hepatic dysfunction
- Overdosage of digoxin
- Hypersensitivity to vitamine D or an overdosage of vitamin D
- Parathyroidectomy
- < 18 years
- Pregnancy
- Mental illness

Design

Study phase :
4
Study type :
Interventional
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
114
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
Etalpha
Generic name :
Alfacalcidol
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
Zemplar
Generic name :
Paricalcitol
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Amsterdam UMC
Approved WMO
Date :
Application type :
First submission
Review commission :
METC Amsterdam UMC

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

ID: 24070
Source: NTR
Title: Research to (cost)effectiveness of paricalcitol in the treatment of secondary hyperparathyroidism

In other registers

Register ID
EudraCT EUCTR2007-006645-41-NL
CCMO NL15946.029.07
OMON NL-OMON24070