Envarsus in Delayed Graft Function: A Phase IV, Randomized, Single Center Study Among Kidney Transplant Recipients With Delayed Graft Function (DGF) to Study the Effect of Envarsus XR in the DGF Recovery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Days Needed to Recover From Delayed Graft Function (DGF)
研究概览
简要总结
Envarsus XR is an extended release tacrolimus designed to deliver tacrolimus more consistently, thus avoiding large fluctuations of tacrolimus trough levels with Envarsus XR compared to immediate release tacrolimus. It is expected that patients with DGF on Envarsus XR will have more stable tacrolimus levels and facilitate early recover from DGF compared to immediate release tacrolimus.
详细描述
This is a single center randomized phase IV trial of comparing extended release Envarsus XR (study drug) once a day vs immediate release tacrolimus twice a day in a new kidney transplant recipients with delayed graft function (DGF). The primary study endpoint is the interval between first dialysis and last dialysis after kidney transplant (duration of DGF). The second end point is the number of tacrolimus or Envarsus XR dose adjustments required during the period of DGF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •Willing to comply with all study procedures and be available for the duration of the study
- •Male or female, at least 18 years of age
- •Documented diagnosis of DGF or need for dialysis or had dialysis within the first week of kidney transplant
- •Current treatment with tacrolimus based regimen or planned to start tacrolimus based immunosuppressive regimen
- •Females of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to randomization, for the duration of study participation, and for 7 days following completion of therapy.
- •A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •Has not undergone a hysterectomy or bilateral oophorectomy; or
- •Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
排除标准
- •History of hypersensitivity or allergy to any of the study drugs or drugs of similar chemical classes
- •Current use of non-tacrolimus based immunosuppressive regimen or no plan to start tacrolimus based regimen
- •Women who are or plan to become pregnant or breast-feeding during the study period
- •Not suitable for study participation due to other reasons at the discretion of the investigator
- •Major post-surgical complications requiring allograft nephrectomy
- •Multi-organ transplant recipients
- •Non kidney transplant recipients
研究组 & 干预措施
Standard of Care
Standard of Care Tacrolimus
干预措施: Tacrolimus (Drug)
Experimental
Envarsus XR
干预措施: Envarsus XR (Drug)
结局指标
主要结局
Number of Days Needed to Recover From Delayed Graft Function (DGF)
时间窗: up to 3 months post transplant
The primary endpoint of the study will be the length of time between first dialysis and last dialysis after kidney transplant (duration of DGF).
次要结局
- Number of Tacrolimus or Envarsus XR Dose Adjustments Required During the Period of DGF(up to 3 months post transplant)