Condition category
Urological and Genital Diseases
Date applied
22/02/2012
Date assigned
17/04/2012
Last edited
01/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Some children who are unwell can have damage caused to their kidneys either by the illness itself, or the drugs used to treat the illness. Currently we measure a substance called creatinine in blood tests to check how well the kidneys are working. However, creatinine is slow to show any damage to the kidney, so we may not find out that damage has occurred until it is too late to reverse it. Also doing this test means having to take a blood sample. A number of substances, which we call biomarkers, can be measured in the urine. We think that some of these biomarkers might be useful at telling us how well a child’s kidneys are working, and whether any damage is occurring.
This study will help us to develop urine biomarker tests that will one day be part of our normal clinical practice, and will improve our care of future children.

Who can participate?
We are asking healthy children aged 0 to 16 years to consider taking part in this study.

What does the study involve?
The study has two parts. Participants can do just the first part, or they can do both parts. Children, and their parents, will be approached for recruitment in a number of different settings: in schools, nurseries, at Alder Hey Children’s Hospital (AHCH) in Liverpool, and children of University of Liverpool or AHCH employees.
Part 1
A single urine sample will be collected from the child. Ideally the urine sample will be collected by asking the child to pass urine into a sterile container.
Part 2
This part will take longer, and will need the child to do four more urine samples at home. They will need to collect:
A morning urine sample once a week for the next three weeks.
One bedtime urine sample the evening before one of the morning urine samples.
The morning samples should be done when the child gets up, and the evening sample just before going to bed. The evening sample will need to be kept in the fridge overnight. The child & their parents will be given sample pots to take home. The sample will need to be brought on the morning of collection to the research team at the site of recruitment.
We will store the urine samples in a freezer, and test for different biomarkers at different times. We will keep the sample until it is used up.

What are the possible benefits and risks of participating?
We do not anticipate any problems. We will choose an appropriate urine collection method for each child. There are no immediate benefits.
If we find the urine biomarkers are too high in a child’s urine sample we will check this again in our laboratory. If it is still high we will ask the child’s general practitioner (GP) to see them.

Where is the study run from?
This research is being run by the University of Liverpool and Alder Hey Children’s NHS Foundation Trust.

When is study starting and how long is it expected to run for?
The study started in March 2012, and is expected to run until October 2014

Who is funding the study?
The study is funded by the Medical Research Council.

Who is the main contact?
Dr Steve McWilliam
S.Mcwilliam1@liverpool.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Stephen J McWilliam

ORCID ID

Contact details

Molecular and Clinical Pharmacology
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 151 795 5407
S.Mcwilliam1@liverpool.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11810

Study information

Scientific title

DEtermining Reference Values for renal biomarkers in healthy children

Acronym

DERiVe

Study hypothesis

Some children who are unwell can have damage caused to their kidneys either by the illness itself, or the drugs used to treat the illness. Currently we measure a substance called creatinine in blood tests to check how well the kidneys are working. However, creatinine is slow to respond to any damage to the kidney, so we may not find out that damage has occurred until it is too late to reverse it. Also doing this test means having to take a blood sample.

A number of substances, which we call biomarkers, can be measured in the urine. We think that some of these biomarkers might be useful at telling us how well a child’s kidneys are working, and whether any damage is occurring.

We need to measure these biomarkers in the urine of normal healthy children so that we know what their normal level is. This will help us when we start measuring the biomarkers in unwell children as we will be able to see any differences. This study will help us to develop urine biomarker tests that will one day be part of our normal clinical practice, and will improve our care of future children.

Ethics approval

NRES Committee North West – Liverpool East, 25th January 2012, ref:12/NW/0060

Study design

Observational study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Kidney function

Intervention

In this study healthy children will be asked to provide a single urine sample. In addition, some will provide four further urine samples over the following 3 weeks (3 morning samples and one evening sample). These urine samples will be analysed for a number of urine biomarkers. The aim of the study is to produce reference values for urine biomarkers in healthy children, to assess variation between individuals, and within the same subject with time of day or over a period of weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured urinary biomarker values

Secondary outcome measures

1. The variation in measured urinary biomarker values between subjects
2. The variation in biomarker values within subjects depending on the time of day, or over a period of weeks

Overall trial start date

01/03/2012

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Male or female, age 0-16 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Current febrile illness
2. History of any kidney problem or urinary tract infections
3. Current medications known to cause renal problems (especially nonsteroidal antiinflammatory drugs such as ibuprofen)
4. Diagnosis of cystic fibrosis (by sweat test or genotype)
5. History of exposure to aminoglycoside antibiotics within the last 3 months

Recruitment start date

01/03/2012

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Molecular and Clinical Pharmacology
Liverpool
L69 3GL
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

UK Medicines for Children Research Network Coordinating Centre
Liverpool
L12 2AP
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (G1000417. ID number 94909)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/12/2016: No publications found in PubMed, verifying study status with principal investigator.