Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Time to First Occurrence of Acute Rejection, Failure, Death
研究概览
简要总结
As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs. However, despite pharmacokinetic studies showing bioequivalence, questions remain regarding the clinical impact of use of generic immunosuppression.
The most important immunosuppressive agent in the modern transplant era is arguably tacrolimus, a calcineurin-inhibitor with a narrow therapeutic index. This study seeks to answer the question regarding the clinical impact of generic tacrolimus use as measured primarily by acute rejection, loss of graft function, and patient death through a randomized trial of 2 phases: Brand tacrolimus only, and Generic A tacrolimus only. Given that kidney transplantations are the most commonly performed transplants with well-defined measures of rejection and graft failure, this organs will be studied in a six-center study designed to accrue the target number of transplant recipients within the one-year study period.
The study has now been branched off into 2 phases. Phase 1: consists of randomization of patients onto brand and generic tacrolimus. This was completed once 40 brand patients were enrolled. Phase 2: consists of patients being enrolled only on generic tacrolimus (standard of care from subject's insurance). This will be completed once there is a total of 160 generic participants. 200 participants total in the study.
详细描述
A prospective, randomized, open-label, multicenter, parallel, observational study to assess safety and efficacy of 200 kidney transplant recipients comparing brand tacrolimus to generic tacrolimus over a one year follow up period. All subjects will receive other immunosuppressive medications including induction therapy (thymoglobulin, basiliximab, or no induction) and maintenance including mycophenolate mofetil and corticosteroid therapy as directed by standard-of-care at each center. Their medication information will be recorded in their study files.
The study population includes recipients of kidney allografts in the first 14 days after transplantation.
The totals of 7 visits over 12 months period are planned as follows. The blood samples specified below are for the translational research study labs. Subjects will continue to receive routine labs as part of their standard of care from their treating physician. These safety labs are done as part of their stand of care from their treating physician.
If the subject needs more study drug medication before his or her next study visit the subject will come in to the clinic to get a new supply.
First (Baseline) Visit (up to 14 days after transplant but before you are discharged from the hospital):
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Brand Tacrolimus Only : Prograf
Arm 1 will receive brand tacrolimus for the entire study
干预措施: Prograf (Drug)
Generic A Only
Arm 2 will receive specific generic tacrolimus for the entire study
干预措施: Tacrolimus (Drug)
结局指标
主要结局
Time to First Occurrence of Acute Rejection, Failure, Death
时间窗: 1 year post-transplant
The definition of graft failure includes re-transplant and/or death and, in case of kidney transplant, also includes return to dialysis. Acute rejection was defined as biopsy-proven rejection according to Banff 2007 criteria. Please see the following article for details of the Banff '07 classification: https://www.sciencedirect.com/science/article/pii/S1600613522056428?via%3Dihub.
次要结局
- Number of Participants With Graft Rejection at 1 Year(1 year post-transplant)
- Number of Participants With Graft Failure at 1 Year(1 year post-transplant)
- Number of Participants With Infectious Episodes at 1 Year(1 year post-transplant)
- Number of Participants With Malignancy at 1 Year(1 year post-transplant)
- Death or Loss-to-follow-up at 1 Year(1 year post-transplant)
- Changes in Lymphocyte Subpopulations and Production of Donor Specific HLA Antibodies(post-transplant)
- Number of Participants Who Adhered to Medication Regimen(post-transplant)
- Quality of Life With Medication Regimen(post-transplant)
- Satisfaction With Medication Regimen(post-transplant)
研究者
Suphamai Bunnapradist
Professor of Medicine, Director of Research
University of California, Los Angeles