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Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations

Study to Evaluate Tolerability of Myfortic With Simulect Induction and Tacrolimus Without Steroids in Three Patient Populations; 1: Kidney/Pancreas Transplants,2: Diabetic Kidney Transplants, and 3: Non-diabetic Kidney Transplants

This study is designed to evaluate the tolerability of Myfortic®/Simulect® combination in diabetic patients in a steroid free regimen. Due to the diverse ethnicity of our transplant recipient population, the study will determine any different responses, including autoimmunity, between Hispanic, and Caucasian, patients.

研究概览

地位

终止

详细说明

Myfortic® is an enteric-coated formulation of the sodium salt derivative of mycophenolic acid (MPA) that is administered to control kidney graft rejection. Myfortic® was developed to improve MPA-related upper gastrointestinal (GI) side effects by delaying the release of MPA until it reaches the large surface of the small bowel. Approximately half of all the kidney transplant recipients in the United States have diabetes mellitus. A recent analysis of approximately 30,000 kidney transplant recipients included in the U.S. Renal Data System showed that 42% of patients had pre-transplant diabetes (1). Moreover, 15% to 20% of patients develop diabetes after transplantation, a condition that is commonly known as post-diabetes mellitus (1-3). It was previously shown that the rate and extent of MPA absorption is minimally affected by diabetes (4). Limited data is available in the current literature on Myfortic® and Simulect® based therapy in diabetic patients.

研究类型

介入性

注册 (实际的)

2

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • Galveston、Texas、美国、77555
        • University of Texas Medical Branch

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
  2. Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
  3. Written inform consent obtained. The patients are willing to participate in the study at UTMB.
  4. Female with negative pregnancy test.
  5. PRA < 20 %.
  6. En-blocks and two kidneys (tx'd at the same time) will be allowed.
  7. Cold Ischemia time ≤ 30 hrs
  8. Hep C patients will be allowed to enroll in this study

Exclusion Criteria:

  1. Multi-organ transplants
  2. Transplant from non-heart beating donor (NHBD) or dual transplants
  3. A-B-O incompatible or positive cross match
  4. Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
  5. Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
  6. Inability to tolerate oral medications
  7. Inability to sign a written consent form or to cooperate with investigators
  8. Use of an investigational medication in the past 30 days.
  9. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
  10. HIV positive patients
  11. History of psychosocial instability
  12. Mental incompetence

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Transplant recipients
All subjects receive identical drug treatment
Gastric emptying tests will be performed at baseline, 6 months and 12 months
其他名称:
  • Gastric motility

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids
大体时间:24 months
Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects
24 months

次要结果测量

结果测量
措施说明
大体时间
GI complications
大体时间:24 months
Gastric emptying test
24 months
Graft function
大体时间:24 months

Renal function assessed by serum creatinine and calculating creatinine clearance.

Pancreas function assessed by glucose control, exogenous insulin requirement, HgbA1C

24 months
Biopsy proven rejection
大体时间:24 months
Renal graft core biopsy will be performed on all suspected rejection.
24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Luca Cicalese, MD、University of Texas

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (实际的)

2012年10月1日

研究完成 (实际的)

2012年10月1日

研究注册日期

首次提交

2011年6月8日

首先提交符合 QC 标准的

2011年6月30日

首次发布 (估计)

2011年7月4日

研究记录更新

最后更新发布 (实际的)

2020年11月17日

上次提交的符合 QC 标准的更新

2020年11月12日

最后验证

2013年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 10-244

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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