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

Not Applicable

Completed

• Conditions: Cystic fibrosis / kidney injury; Nutritional, Metabolic, Endocrine; Cystic fibrosis

• Registration Number: ISRCTN43716844
• Lead Sponsor: niversity of Liverpool

Brief Summary

1. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29572451 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-08
• Study Completion: 2014-10-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. The association between urinary biomarker values and conventional measures of renal function [serum urea and creatinine, estimated glomerular filtration rate (eGFR)]<br> 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<br> 3. An analysis of changes in urinary biomarker values in the same patient with repeated courses of tobramycin<br>