NCT02706678已完成4 期
Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study
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
- 105
- 主要终点
- Change from baseline in creatinine level
研究概览
简要总结
The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-65 years of age, male or female
- •1-5 years after kidney transplantation
- •The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
- •The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
- •At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
- •gingival hyperplasia and treatment requested by the patient
- •polytrichia and interventional therapy requested by the patient
- •post-transplantation hypertension
- •post-transplantation hyperlipemia (total cholesterol>5.7 mmol/L (220 mg/dl))
- •Serum creatinine<200 μmol/l ( 2.3 mg/dl)
- •A promise is made to take contraceptive measures during the study (women at childbearing ages).
排除标准
- •Patients having accepted transplantation of other organs apart from kidney transplantation
- •Patients with 24-hour urine protein>2 g
- •Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
- •Patients with refractory infectious foci
- •Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
- •Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
- •Patients allergic to tacrolimus or other basic medications
- •Pregnant or lactating women
- •Patients having participated in other clinical trials within the previous month
- •Other patients who are considered by doctors unsuitable for the study
研究组 & 干预措施
Tacrolimus sustained-release capsule group
Experimental
Oral
干预措施: Tacrolimus sustained-release capsule (Drug)
结局指标
主要结局
Change from baseline in creatinine level
时间窗: Baseline and Week 24
次要结局
- Change from baseline in creatinine level(Baseline and Weeks 1, 2, 4, 8 and 12)
- Incidence of rejection reaction after drug use(Up to Week 24)
- Change from baseline in blood pressure(Baseline and Weeks 1, 2, 4, 8, 12 and 24)
- Plasma concentrations of tacrolimus(Weeks 1, 2, 4, 8, 12 and 24)
- Change from baseline in fasting blood glucose(Baseline and Weeks 1, 2, 4, 8, 12 and 24)
- Change from baseline in gingival hyperplasia(Baseline and Week 24)
- Change from baseline in polytrichia(Baseline and Week 24)
- Safety assessed by Adverse Events(Up to 24 weeks)
- Change from baseline in blood lipid(Baseline and Weeks 1, 2, 4, 8, 12 and 24)
- Change from baseline in liver function(Baseline and Weeks 1, 2, 4, 8, 12 and 24)
研究者
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