NCT01839929已完成4 期
A Multicenter, Open-label, Single-arm, Non-inferiority Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF® in Stable Kidney Transplant Patients Converted From a PROGRAF® Based Immunosuppressive Regimen
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
- 138
- 主要终点
- Change in glomerular filtration rate (GFR) at Week 24 from baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received a kidney transplant at least 12 months ago prior to enrollment.
- •Patients have taken unchanged dosage of Prograf® and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment.
- •Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
- •Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial.
- •Patients are considered clinically stable by observer's judgment.
- •Patients must understand the purpose and risk of participating the trial and signed on the written consent.
排除标准
- •Patients have previously received an organ transplant other than a kidney.
- •Patients have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
- •Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
- •Patients have a known hypersensitivity to Prograf® or tacrolimus.
- •Patients whose medical condition are able to interfere with the study objectives.
- •Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer.
- •Patients have been participated in another clinical trial, or treated with drugs of clinical trial within 28 days prior to enrollment.
- •Patients have been taken prohibited combination agents within 28 days prior to enrollment.
- •Patients are pregnant or lactating.
- •Patient are HIV-positive.
- •Patients are not able to keep the scheduled visit.
- •Patients whose GFR (MDRD) is in the level of <30 mL/min.
- •Patients who are at the condition of 'Creeping creatinine (defined by 20% increase within 6 months prior to enrollment)
- •Patients whose SGPT/AST and/or SGOT/ALT levels have been elevated greater than 2 times the upper value of the normal range.
- •Patients have FSGS or MPGN Type II as underlying diseases.
- •Patients are with cirrhosis
研究组 & 干预措施
Prograf/Advagraf
Experimental
conversion from Prograf to Advagraf
干预措施: Prograf (Drug)
Prograf/Advagraf
Experimental
conversion from Prograf to Advagraf
干预措施: Advagraf (Drug)
结局指标
主要结局
Change in glomerular filtration rate (GFR) at Week 24 from baseline
时间窗: Baseline and Week-24
次要结局
- Change in Blood Pressure (BP) at Week 24 from baseline(Baseline and Week-24)
- Change in HbA1c at Week 24 from baseline(Baseline and Week-24)
- Change in tacrolimus blood trough level at Week 24 from baseline(Baseline and Week-24)
- Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests(For 24 weeks)
- Overall frequency of acute rejection(For 24 weeks)
研究者
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