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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults (age 18 to 65 years of age), male or female Hispanic or Caucasian.
- •Primary kidney or kidney transplant patients (cadaveric, living related, or living unrelated)
- •Written inform consent obtained. The patients are willing to participate in the study at UTMB.
- •Female with negative pregnancy test.
- •PRA < 20 %.
- •En-blocks and two kidneys (tx'd at the same time) will be allowed.
- •Cold Ischemia time ≤ 30 hrs
- •Hep C patients will be allowed to enroll in this study
排除标准
- •Multi-organ transplants
- •Transplant from non-heart beating donor (NHBD) or dual transplants
- •A-B-O incompatible or positive cross match
- •Conditions which significantly alter the absorption, distribution, and metabolism (except for diarrhea) of medications.
- •Women of childbearing potential not using contraception method(s) as well as women who are breastfeeding
- •Inability to tolerate oral medications
- •Inability to sign a written consent form or to cooperate with investigators
- •Use of an investigational medication in the past 30 days.
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- •HIV positive patients
- •History of psychosocial instability
- •Mental incompetence
结局指标
主要结局
Tolerability of Myfortic in combination with Simulect and Tacrolimus without steroids
时间窗: 24 months
Assure that immunosuppression protects graft function by decreased incidence of rejection and side effects
次要结局
- GI complications(24 months)
- Biopsy proven rejection(24 months)
- Graft function(24 months)