Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic Fibrosis

Phase 1

• Conditions: Aminoglycoside-induced nephrotoxicity; MedDRA version: 18.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 18.0Level: PTClassification code 10069022Term: Kidney injury molecule-1System Organ Class: 10022891 - Investigations; MedDRA version: 18.0Level: LLTClassification code 10067571Term: NephrotoxicitySystem Organ Class: 100000004857; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2014-002387-32-GB
• Lead Sponsor: niversity of Liverpool

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-27
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• 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.
6. Able to take tablets.

Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Existing treatment with a statin.
2.Previous adverse reaction to a statin.
3.Co-enrolment in other drug trials*, or completion of a previous CTIMP within the last 30 days
4.Previous randomisation in the PROteKT trial
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 and Simepravir.
6.Female participants who are pregnant or lactating (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<60ml/min/1.73m², 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 glucose-galactose malabsorption.
15.Patients who are Hepatitis C positive or HIV-positive.

*Patients who are currently taking part in TORPEDO-CF are allowed to take part in PROteKT as long as their date of randomisation into TORPEDO-CF is not within the previous six months of the screening date for PROteKT.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified