NCT02268201终止4 期
A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients
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
- 17
- 主要终点
- medication adherence
研究概览
简要总结
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.
详细描述
The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens.
The secondary objectives of this study are:
- To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens.
- To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens.
- To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients.
- To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
- •The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
- •SCr< 200 μmol/l ( 2.3 mg/dl)
- •Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
- •Understand and sign the approved informed consent form
排除标准
- •Patients who have had other solid organ transplantations
- •24 hours proteinuria>2g
- •SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
- •Patients suffering from serious infection lesions
- •Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
- •Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history
- •Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients
- •Pregnancy or lactating women
- •Patients have participated in another clinical trial in the past month
- •Patient refuses to sign informed consent form
- •Patient not willing to continue in the study and wants to withdraw from the study
- •Poor adherence or lost to follow-up
- •Violation of protocol
- •Severe adverse events occurred need to withdraw the study according to investigator's judgment
- •Pregnancy
研究组 & 干预措施
ADV group
Experimental
Once daily
干预措施: Advagraf (Drug)
PRG group
Experimental
Twice daily
干预措施: Prograf (Drug)
结局指标
主要结局
medication adherence
时间窗: Up to 52 weeks after switching
VAS will be used to evaluate adherence between PRG and ADV
次要结局
- endogenous creatinine clearance rate (Ccr)(Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52)
- Safety assessed by the incidence and severity of adverse events(Up to 52 weeks after switching)
- Calculated glomerular filtration rate(Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52)
- fasting blood-glucose (FBG)(Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52)
- blood lipids(Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52)
- liver function (AST, ALT and bilirubin)(Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52)
研究者
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