NCT02500212已完成4 期
OPEN-LABEL, MULTICENTRE, RANDOMIZED CLINICAL TRIAL TO COMPARE THE PHARMACOKINETICS OF ENVARSUS® TABLETS AND ADVAGRAF® CAPSULES ADMINISTERED ONCE DAILY IN ADULT DE-NOVO KIDNEY TRANSPLANT PATIENTS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL
研究概览
简要总结
Open-label, multicentre, randomized clinical trial to compare the pharmacokinetics of ENVARSUS® tablets and ADVAGRAF® capsules administered once daily in adult de-novo kidney transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Recipients of a kidney transplant from a deceased donor or a living donor
排除标准
- •Recipient of any transplanted organ other than a kidney;
- •Recipients of a bone marrow or stem cell transplant;
- •Recipients of a kidney from a cardiac death donor;
- •Recipients of a kidney from an ABO incompatible donor;
研究组 & 干预措施
ENVARSUS tablets
Experimental
Envarsus® (tacrolimus) prolonged-release tablets provided in 0.75 mg, 1.0 mg and 4.0 mg dose strengths.
Envarsus® tablets will be administered orally once daily in the morning
干预措施: ENVARSUS® (Drug)
ADVAGRAF capsules
Active Comparator
Advagraf® (tacrolimus) prolonged-release hard capsules provided in 0.5 mg, 1.0 mg, 3.0 mg and 5.0 mg dose strengths.
Advagraf® capsules will be administered orally once daily in the morning
干预措施: ADVAGRAF® (Drug)
结局指标
主要结局
Tacrolimus Area under the curve (AUC 0-24h)r h*pg/mL
时间窗: pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 16.0, 20.0, 24.0 hr post-dose
次要结局
- Heart Rate, (beats per minute)(before dosing)
- Serum creatinine (mg/dL)(before dosing)
- estimated glomerular filtration rate (eGFR) mL/min;(before dosing)
- Qt (milliseconds)(before dosing)
- Tacrolimus concentration 24 hours post-dose (C24hr) pg/mL(24.0 hr post-dose)
研究者
研究点 (7)
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