Rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis

Phase 2

Completed

• Conditions: Nutritional, Metabolic, Endocrine; Topic: Children; Subtopic: All Diagnoses; Cystic fibrosis; Disease: All Diseases

• Registration Number: ISRCTN26104255
• Lead Sponsor: niversity of Liverpool (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-05
• Study Completion: 2016-09-01
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age 10 to 18 years inclusive
2. Diagnosis of cystic fibrosis (established by sweat test or genotype)
3. Planned, clinically indicated, course of treatment with IV tobramycin
4. Ability to give informed consent
5. Willingness to comply with all study requirements.

Exclusion Criteria

1. Unable to take tablets
2. Existing treatment with a statin
3. Previous adverse reaction to a statin
4. Coenrolment in other drug trials, or completion of a previous CTIMP within the last 30 days
5. Patients taking any of the following medications: ciclosporin, protease inhibitors, fibrates, ezetimibe, erythromycin (but not other macrolides), eltrombopag, dronedarone, itraconazole, coumarins, oral contraceptives, nicotinic acid, fusidic acid
6. Female participants who are pregnant or lactating or refuse a pregnancy test if of childbearing potential (female participants of childbearing potential must use a barrier method of contraception if sexually active whilst taking rosuvastatin and for 7 days afterwards)
7. Patients of Asian ancestry (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
8. Patients with renal disease (eGFR < 60 ml/min/1.73sq. m, using the Schwartz formula, in the 6 months preceding randomisation)
9. Patients with current elevation in transaminases exceeding 3x the upper limit of normal
10. Family history, or personal history, of hereditary muscular disorders
11. Patients with myopathy
12. Patients with a history of, or active alcohol abuse
13. Patients with hypothyroidism
14. Patients with galactose intolerance, the Lapp lactase deficiency, or glucosegalactose malabsorption

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean fold-change in urinary KIM-1; Timepoint(s): Urinary KIM-1 measured daily during tobramycin exposure. This will be assessed using the difference in mean fold-change in urinary KIM-1 from baseline to peak concentration during exposure to tobramycin between the rosuvastatin-treated arm and control arm.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration