The RITA-study -- An Open Study to Evaluate the Blood Lipid Lowering Effect of Rosuvastatin Versus Fluvastatin and the Bilateral Interaction Between Everolimus and Rosuvastatin in Renal Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin
研究概览
简要总结
Renal transplant recipients need life long immunosuppression and one of the new drugs is everolimus. Everolimus is a potent immunosuppressive drug and one of the main side-effects are increased blood cholesterol levels. Many renal transplant recipients are treated with a cholesterol lowering agent, mainly fluvastatin. Rosuvastatin is a new cholesterol lowering drug on the market with a potential higher cholesterol lowering potency. In the present study the investigators will examine the hypothesis that rosuvastatin reduce cholesterol levels more than fluvastatin in renal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Renal transplant recipients with stable renal function (plasma creatinine < 200 µmol/L)
- •Renal transplant recipients on an everolimus and fluvastatin based therapy for minimum 3 months prior to inclusion
- •> 18 years of age
- •Male patient or female patient without childbearing potential (surgically sterilized or postmenopausal) or if female of childbearing potential; is not lactating, has a negative pregnancy test at screening and is willing to utilize an effective method of contraception throughout the study period and for 90 days following discontinuation of the study drugs
- •Signed informed consent
排除标准
- •Patients experiencing an acute rejection episode within 2 weeks before or after inclusion, whether proven by biopsy or not
- •Patients with a known hypersensitivity to rosuvastatin
- •Change in enzyme inducing or inhibiting drugs within the last 2 weeks prior to and throughout the study [e.g. barbiturates, rifampicin, ketoconazole, erythromycin, cimetidine and similar drugs]
- •Pregnant or nursing mothers
研究组 & 干预措施
Rosuvastatin
Rosuvastatin treatment for 4 weeks
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
compare the treatment efficacy (blood lipid lowering effect) of rosuvastatin versus fluvastatin
时间窗: 4 weeks
Compare the blood lipid levels before and after switch from fluvastatin to rosuvastatin
Area Under Curve (AUC) of rosuvastatin in renal transplant recipients treated with everolimus. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hours post dose.
时间窗: 4 weeks
Compare 24-h pharmacokinetics of renal transplant recipients with historic controls
次要结局
- 1. Area Under Curve (AUC) of everolimus during rosuvastatin versus fluvastatin therapy, including intracellular everolimus concentrations within T-lymphocytes. Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 hours post-dose.(4 weeks)
- 2. Investigate P-gp activity in whole blood in everolimus treated patients(4 weeks)
- 3. Study inter individual variation in rosuvastatin and everolimus pharmacokinetics in renal transplant recipients due to polymorphism in the genes encoding P-gp, OATP1B1 and CYP3A5(4 weeks)
- 4. Compare effect of rosuvastatin versus fluvastatin therapy on the renal function (eGFR)(4 weeks)