Research with human participants

Overview of medical research in the Netherlands

FGF23 response in hypophosphatemia

Published:
Last updated:

to determine the normal FGF23 response in case of hypophosphatemia

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Nephropathies
Study type
Interventional

ID

NL-OMON42928

Source

ToetsingOnline

Brief title

FGF23 response in hypophosphatemia

Condition

  • Nephropathies

Synonym

hypophosphatemia, low bood phosphate level

Research involving

Human

Sponsors and support

Primary sponsor :
Radboud Universitair Medisch Centrum
Source(s) of monetary or material Support :
subsidie college zorgverzekeringen

Intervention

Keyword :
FGF23, phosphate

Outcome measures

Primary outcome

The main study parameter is the level of FGF23 at phosphate levels below 0.50

mmol/l

Secondary outcome

PTH levels

Background summary

Hypophosphatemia due to renal phosphate wasting can be the consequence of a
long list of both acquired and inherited disorders. An important differential
diagnosis is tumour induced osteomalacia (TIO), mostly caused by FGF23
producing mesenchymal tumours. The main problem in the evaluation of patients
with renal phosphate wasting however is the interpretation of FGF23 levels. It
is suggested that hypophosphatemia itself should lower FGF23 levels but this is
never systematically studied.

Study objective

to determine the normal FGF23 response in case of hypophosphatemia

Study design

prospective intervention study in which healthy volunteers will receive
lanthanum carbonate until they develop a hypophosphatemia of <0.50 mmol/l.

Intervention

lanthanum carbonate

Study burden and risks

participants risk developing symptoms related to hypophosphatemia such as
general body weakness and neuromuscular complaints. this will only be for a
short period as the lanthanum carbonate will bes stopped as soon a
hypophosphatemia is accomplished.

Public
Radboud Universitair Medisch Centrum

Geert Grooteplein Zuid 8 Geert Grooteplein Zuid 8
6500 HB Nijmegen 6500 HB
NL
Scientific
Radboud Universitair Medisch Centrum

Geert Grooteplein Zuid 8 Geert Grooteplein Zuid 8
6500 HB Nijmegen 6500 HB
NL

Listed location countries

Netherlands

Age

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

Inclusion criteria

age * 18 years

Exclusion criteria

* any medical history
* inability to give informed consent
* pregnancy
* medication use (except for oral anti contraceptives)

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Diagnostic

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
10
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
lanthanum carbonate
Generic name :
fosrenol
Registration
:
Yes - NL outside intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)
Approved WMO
Date :
Application type :
First submission
Review commission :
CMO regio Arnhem-Nijmegen (Nijmegen)

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
EudraCT EUCTR2016-002602-39-NL
CCMO NL57379.091.16