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Urinary biomarkers of aminoglycoside-induced nephrotoxicity in children with cystic fibrosis

URinary Biomarkers of Aminoglycoside-induced Nephrotoxicity in children with Cystic Fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN43716844
Enrollment
120
Registered
2012-05-08
Start date
2012-03-01
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Cystic fibrosis / kidney injury Nutritional, Metabolic, Endocrine Cystic fibrosis

Interventions

In this study children and young adults with CF will be asked to provide a number of urine samples. They will provide routine urine samples when they attend outpatient appointments, and they will also

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 0-20 years, either sex (Some patients with CF will continue to be seen in a Paediatric CF clinic beyond the age of 16 and will therefore be included by having a higher upper age limit) 2. Diagnosis of cystic fibrosis (established by sweat test or genotype)

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
The mean difference in urinary biomarker value between samples collected during tobramycin treatment, and samples collected when not receiving tobramycin. This will be calculated for each biomarker measured over the time course of each participants involvement in the study.

Secondary

MeasureTime frame
1. The association between urinary biomarker values and conventional measures of renal function [serum urea and creatinine, estimated glomerular filtration rate (eGFR)] 2. The association between urinary biomarker values and cumulative lifetime aminoglycoside exposure, compared to biomarker values in children with CF who have never received aminoglycosides and to a healthy children cohort 3. An analysis of changes in urinary biomarker values in the same patient with repeated courses of tobramycin

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026