Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Changes in the percentage of blood immunologic markers
研究概览
简要总结
This will be a single center, prospective, open-label, randomized, controlled trial comparing Envarsus XR® to twice-daily tacrolimus. The targeted population will be patients with end stage renal disease listed for primary solitary kidney transplant. Transplant Surgery is not part of the study.
详细描述
Participants will be identified through the Department of Transplantation Surgery at the University of Kentucky. Participants will be pre-screened by the department for entry into the study. The investigator will determine if the participant meets study eligibility requirements.
The purpose of this research is to gather information on how safe and effective of Envarsus® is when compared to twice-daily tacrolimus. The results of this study will be shared with the company providing financial support for the study, the Food and Drug Administration and other federal agencies, if required.
All participants that successfully meeting inclusion criteria will be randomized (like the flipping of coin) to Envarsus vs. Tacrolimus at the time of transplant.
Participants will be randomized to one of two treatment arms. Treatment begins on post-op day 1.
- Treatment: Envarsus® 0.07-0.14 mg/kg/day every morning
- Control: Generic tacrolimus 0.1-0.2 mg/kg/day in 2 divided doses given every 12 hours
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in English able to understand and provide informed consent.
- •End stage renal disease listed for primary solitary kidney transplant.
- •Willing to participate in the study and comply with study requirements as evidenced by signed IRB-approved informed consent.
- •Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion.
排除标准
- •Previously undergone organ, tissue or cell transplant
- •Allergic to Tacrolimus or MMF (Cellcept)
- •Chronic use of blood thinners
- •Previous chronic use of glucocorticoids or other immunosuppression, or biologic immunomodulators (prescribed for the treatment of serious inflammatory disorders)
- •Significant or active infection
- •Diagnosed with HIV, Hepatitis B or C, Herpes simplex virus, Varicella-Zoster virus, Epstein-Barr virus
- •Have or have had cancer with in the past 3 years
- •Have taken part in another study that involved an investigational drug within the last 12 months.
- •Have a history of delayed or abnormal wound healing
- •Are pregnant or breastfeeding
- •Had a transfusion within the past 3 months
- •Have or plan to be receive a live vaccination (intranasal influenza measles, mumps, rubella, oral polio, yellow fever, varicella)
- •Are unable or unwilling to comply with study protocol or procedures.
- •Current use anticoagulation medication
研究组 & 干预措施
Tacrolimus
0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally
干预措施: Tacrolimus (Drug)
Envarsus XR
0.07-0.14 mg/kg/day every morning orally
干预措施: Envarsus XR (Drug)
结局指标
主要结局
Changes in the percentage of blood immunologic markers
时间窗: Time of transplant and six months post-transplant
We will monitor the lymphocyte profile in blood in response to these 2 different treatments. The lymphocyte profile test will be performed by multi-parametric flow cytometry analysis with a panel of specific flourochrome-conjugated antibodies to selectively determine the following sub-populations: 1. Circulating T cells: CD4/CD8 rates and determine the following CD4 subpopulations: effector TH1, TH2, TH9, Tfh, and regulatory/suppressor T cells. 2. Circulating B cells (number and percentage of naïve, activated, memory and plasma B cells. 3. Circulating NK cells (mature and immature)
1. Change in the percentage of donor specific antibodies
时间窗: Time of transplant and six months post-transplant
We will check these donor specific antibodies to: HLA-A, -B and -C; or HLA-DR, -DQ and -DP. We will quantify the expression of these markers by Flow Cytometry analysis and reported as mean fluorescence intensity (MFI) units.
次要结局
- Changes in creatinine clearance(Time of transplant and six months post-transplant)
研究者
Roberto Gedaly
Sponsor/Investigator
University of Kentucky