NCT02963103终止4 期
A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change from baseline in GFR
研究概览
简要总结
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
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 before enrollment.
- •Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
- •Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
- •Serum creatinine < 2.3 mg/dl at enrollment
- •Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
- •Patients considered clinically stable
排除标准
- •Patients who have previously received an organ transplant other than a kidney.
- •Patients who 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 who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
- •Proteinuria > 2 g/24 hrs.
- •Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).
- •Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.
- •Patients who have liver cirrhosis.
- •Patients who are pregnant or breastfeeding.
- •Patients who had been HIV-positive.
- •Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.
- •Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.
- •Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.
- •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 at the risk of drug abuse or mental disorders or communicate difficulties.
研究组 & 干预措施
Tacrolimus group
Experimental
oral
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Change from baseline in GFR
时间窗: Baseline and Week 24
GFR: glomerular filtration rate
次要结局
- Change from baseline in total cholesterol(Baseline and Week 24)
- Change from baseline in Triglycerides(Baseline and Week 24)
- Change from baseline in LDL(Baseline and Week 24)
- Change from baseline in the number of antihypertensive drugs(Baseline and Week 24)
- Change from baseline in HDL(Baseline and Week 24)
- Change from baseline in the number of antihyperlipidemic drugs(Baseline and Week 24)
- Change from baseline in number of participants who have had gingival hypertrophy(Baseline and Week 24)
- Change from baseline in blood pressure(Baseline and Week 24)
- Change from baseline in number of participants who have had hirsutism(Baseline and Week 24)
- Overall incidence rate of adverse events(up to Week 24)
- Proportion of participants with organ survival(up to Week 24)
- Acute rejection rate confirmed by biopsy(up to Week 24)
- Proportion of participants with patient survival(up to Week 24)
- Ratio of mean dose of cyclosporine to tacrolimus(up to Week 24)
研究者
研究点 (1)
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