THE KIMONO-STUDY is designed to study the consequences of having an SFK from childhood. Furthermore, a tailor made risk profil will be designed for children with an SFK, based on individual risk factor (for example co-morbidity, genetic aberrations…
ID
Source
Brief title
Condition
- Other condition
- Renal and urinary tract disorders congenital
- Genitourinary tract disorders NEC
Synonym
Health condition
Genetica
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
KIMONO PRO: Prevalence of renal injury (defined as hypertension, proteinuria
and/or a decrease in glomerular filtration rate) in children with an SFK.
KIMONO GENE: Identification of new genetic mutations prevalent in children with
an SFK.
KIMONO BEGIN: National incidence of SFK.
Secondary outcome
KIMONO PRO: Devolpment of *early* markers for renal injury.
KIMONO GENE: Prevalence of genetic mutations.
KIMONO BEGIN: Follow-up of a cohort of children with an (antenatally diagnosed)
SFK.
Background summary
Children with a solitary functioning kidney (SFK) are at increased risk to
develop renal injury from childhood onwards. However, specific risk factors are
unknown and consensus about clinical follow-up is absent.
An SFK can be of congenital origin (caused bij unilateral renal agenesis or
multicystic dysplastic kidney disease), but can also be acquired due to
unilateral nephrectomy in childhood caused by underlying disease.
We hypothesize that children with both types of SFK will have an increased risk
for renal injury. This is most likely caused by renal mass reduction, which
sets a vicious cycle of hyperfiltration leading to glomerulosclerosis and an
ongoing loss of nephrons. In the long run, renal injury comes to clinical
expression as hypertension, proteinuria and a decrease in glomerular filtration
rate. This 'hyperfiltration hypothesis', designed by Brenner and co-workers,
however is only confirmed in human studies.
THE KIMONO STUDY will test the hyperfiltration hypothesis in children with an
SFK.
Study objective
THE KIMONO-STUDY is designed to study the consequences of having an SFK from
childhood. Furthermore, a tailor made risk profil will be designed for children
with an SFK, based on individual risk factor (for example co-morbidity, genetic
aberrations etc.).
Study design
THE KIMONO-STUDY consists of 3 separate studies:
* KIMONO PRO has a cross-sectional study design on parameters for renal injury
in children with an SFK
* KIMONO GENE performs genetic analysis in children with an SFK
* KIMONO BEGIN is an epidemiological study and determines the national
incidence number of children with an SFK. Also a prenatally diagnosed cohort
will be designed.
Study burden and risks
THE KIMONO-STUDY is specifically designed to be performed in children. The
nature and extent of the burden and risks associated with participation to this
study are limited, or even absent. An extra blood sample will be drawn together
with a subsequent urine sample which is partly used for proteomics.
Furthermore, a 24h ambulatory blood pressure measurement will be perfomed and
children and their parents will be asked to fill in a non-invasive questionaire.
The study parameters of THE KIMONO-STUDY could be of importance in the
prevention of the development of diseae as well as to hamper unnecessary
'hospitalization' of these children. In the long run, we therefore hold the
opinion that participation to this study is beneficial for children with an
SFK.
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Age <18 yrs
Solitary functioning kidney (from congenital or acquired origin, defined as <10% activity on DMSA-scan)
Exclusion criteria
- treatment for malignant disease during study protocol
- absent informed consent
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 |
|---|---|
| CCMO | NL39074.029.12 |