ISRCTN26104255已完成2 期
Phase IIa, randomised, controlled, open-label trial of rosuvastatin for the prevention of aminoglycoside-induced kidney toxicity in children with cystic fibrosis
niversity of Liverpool (UK)0 个研究点目标入组 50 人开始时间: 2014年9月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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