Drug Interaction and Pharmacokinetic Assessment of Everolimus When Coadministered With Atorvastatin in Renal Transplantation Recipient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 12-hour area under the time concentration curve of everolimus
研究概览
简要总结
Hypothesis : In renal transplantation recipient who received immunosuppressive drug "certican" and have hypercholesterolemia will get lipid lower drug-HMG Co-A reductase inhibitors. Because atorvastatin and everolimus have metabolism via Cytochrome P450 subfamily 3A4 both, so investigator made the hypothesis that when patients received everolimus with atorvastatin will change area under the time concentration curve of everolimus.
详细描述
Population : Thai postrenal transplantation recipient who received everolimus and have hypercholesterolemia in posttransplantation clinic at Faculty of Medicine, Chulalongkorn University.
Study Design : Experimental study, Two-sample crossover study Sample size calculation :N = 18 Primary outcome : 12-hour area under the time concentration curve of everolimus Secondary outcome : renal function (serum creatinine, creatinine clearance)
Method :
- Patients will random to everolimus or everolimus with atorvastatin 20 mg arm for 1 month.
- Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
- After first blood sample, patients will received everolimus only for 1 month (wash out period)
- Patients will switch to another arm eg.patient who had received everolimus will switch to everolimus with atorvastatin 20 mg for 1 month
- Take blood sample for everolimus concentration at time 0,0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 hour
- Everolimus level will analyse for 12-hour AUC of everolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post renal transplantation recipient who received immunosuppressive drug Everolimus and has hypercholesterolemia
- •Co everolimus level within 3-12 ng/mL
- •Informed consent
- •Patient can follow research methodology
排除标准
- •Patient don't want to participate in the study
- •Post renal transplantation recipient who have normal lipid profile
研究组 & 干预措施
everolimus
Everolimus administration with adjusted dose to target C trough (C0) level between 3-12 ng/mL
干预措施: Atorvastatin 20 mg (Drug)
everolimus with atorvastatin 20 mg
Co-administration of everolimus and atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.
Atorvastatin 20 mg/day (fixed dose)
干预措施: Everolimus (Drug)
结局指标
主要结局
12-hour area under the time concentration curve of everolimus
时间窗: 3 months
compare when taking only everolimus to coadministered with atorvastatin
次要结局
- Renal function(3 months)
- Liver function test(3 month)
- Lipid profile(3 month)
- Rhabdomyolysis(3 month)
研究者
ANOCHA WANITCHANONT
Department of Medicine, Faculty of Medicine, Chulalongkorn University
Chulalongkorn University