NCT01742676已完成4 期
A Single Center, Open-label, Randomized Pilot Study to Evaluate the Safety and Efficacy of Modified-release Tacrolimus, ADVAGRAF®, Versus Those of Twice-daily Tacrolimus, PROGRAF®, in Stable Renal Recipients (SINGLE)
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
- 100
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients who meet the following inclusion criteria should be enrolled.
- •Patients who received a kidney at least within 12 months of their study enrollment (from a deceased or living donor)
- •Patients whose tacrolimus dose have not been changed in at least 12 weeks from their study enrollment and whose minimum blood tacrolimus concentration mean value is within 3-10 ng/ml
- •Female patients who showed a negative result in the serum pregnancy test and who agreed to use an effective contraceptive method during the study period
- •Patients who are clinically stable based on the judgment of the investigator
- •Patients who were given enough information regarding the study, understood the objectives and risks of the study, and signed the informed consent form
排除标准
- •Patients who fall under any of the following criteria should not be enrolled in this study.
- •Patients who had received any other organ except a kidney
- •Patients who showed an acute rejection reaction within 12 weeks of their enrollment or who showed an acute rejection reaction that required antilymphocyte antibody therapy within 24 weeks
- •Patients who were diagnosed with a newly developed malignant tumor (Patients with successfully treated squamous cell/basal cell carcinoma can be enrolled, though.)
- •Patients who have a known allergy to the investigational drug (the test/control drug) or to tacrolimus
- •Patients who have an unstable medical condition that may affect the evaluation of the study's objectives based on the investigator's judgment
- •Patients who have any form of drug abuse or mental illness that might complicate communication with the investigators based on the investigator's judgment
- •Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment
- •Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment
- •Patients who are pregnant or breastfeeding
- •Patients who had been HIV-positive
- •Patients who are considered non-compliant with the scheduled study visits in the protocol
- •Patients who have abnormal kidney functions or a serum creatinine level higher than 1.6 mg/dL/GFR (MDRD) or less than 30 mL/min at the screening visit
- •Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment)
- •Patients who have abnormal liver functions: i.e., whose SGPT/ALT and/or SGOT/AST and/or bilirubin is twice higher than the normal range in the center, and who have liver cirrhosis
- •Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN)
研究组 & 干预措施
ADVAGRAF group
Experimental
干预措施: ADVAGRAF (Drug)
PROGRAF group
Active Comparator
干预措施: PROGRAF (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: at 24 weeks
次要结局
- Glomerular Filtration Rate (GFR)(at 24 weeks)
- Survival rate of the grafts(at 24 weeks)
- Subject's physical condition (SF-35)(at 24 weeks)
- Incidence of rejection reactions(at 24 weeks)
- Blood pressure(at 24 weeks)
研究者
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