Optimum Immunosuppression in Renal Transplant Recipients at High Risk of Developing New Onset Diabetes After Transplantation: A Multicenter, Prospective, Controlled and Randomized Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 134
- 试验地点
- 10
- 主要终点
- Patients Treated With Insulin or Oral Antidiabetic Drugs
研究概览
简要总结
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, Tacrolimus increases 2 times the risk of NODAT as compared to CsA.
详细描述
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. CsA and Tacrolimus are the basis of modern immunosuppression. Tacrolimus is superior to CsA in terms of acute rejection and graft function. However, increases 2 times the risk of NODAT as compared to CsA. Objectives: a) To compare the incidence of NODAT and glucose intolerance with 3 different regimes: Tacrolimus with rapid steroid withdrawal; Tacrolimus with steroids minimization; and CsA with steroid minimization; b) To compare acute rejection rate, renal function and graft and patient survival between different regimes; and c) to investigate the influence of different regimes on subclinical atheromatosis. A total of 210 patients will be randomized. The primary efficacy variable will be NODAT or glucose intolerance at 1 year; secondary efficacy variables will be acute rejection, renal function, and changes of carotid intima-media thickness over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Primary renal transplant recipients with end stage renal disease
- •No prior history of diabetes mellitus before transplant
- •Absence of Immunologic risk defined by the investigator criterion and Panel Reactive Antibody (PRA) < 50%
- •Absence of severe infection and hepatitis C or B infection
- •Efficient contraception in women during the study
- •Additionally must meet one of these "Metabolic Criteria
- •Recipient age >or =60 or
- •Recipient age between 45 and 59 years and at least one of the following metabolic criteria: Prior to transplantation Triglycerides (TGS) >200mg/dl or the combination of a body mass index (BMI)> 27 and Triglycerides>150 mg/dl or the combination of HDL-cholesterol<40 mg/dl for men or <50 mg/dl for women and Triglycerides >150 mg/dl.
排除标准
- •Patients with type I or II diabetes prior to transplantation defined by the American Diabetes Association (ADA) criteria
- •Recipient age under 45
- •Patients receiving a second renal transplant
- •Patients with high immunological risk or PRA (panel reactive antibody level) >or =50%
- •Severe infection or hepatitis C or B infection.
- •Dual renal transplant or double transplant with any other organ.
研究组 & 干预措施
Tacrolimus with rapid steroid withdrawal
Basiliximab induction. Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.
干预措施: Tacrolimus with rapid steroid withdrawal (Drug)
Tacrolimus with steroids minimization
Basiliximab induction.Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
干预措施: Tacrolimus with steroids minimization (Drug)
CsA with steroid minimization
Basiliximab induction. Ciclosporin A (CsA) plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal
干预措施: CsA with steroid minimization (Drug)
结局指标
主要结局
Patients Treated With Insulin or Oral Antidiabetic Drugs
时间窗: 1 year
Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT)
时间窗: 1 year
American Diabetes Association criteria (ADA) including an oral glucose tolerance test.
Primary Outcome Measure (Glucose Intolerance)
时间窗: 1 year
Glycemia \>=140 and \<200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria.
次要结局
- Renal Function(1 year)
- Number of Antihypertensive Drugs Patients Reported Taking.(1 year)
- Lipidic Profile (LDL-c)(1 year)
- Percentage of Patients Using Statins(1 year)
- Percentage of Patients Using Acetylsalicylic Acid (ASA)(1 year)
- Rejection(1 year)
- Blood Pressure(1 year)
- Proteinuria(1 year)
- Lipidic Profile (Cholesterol)(1 year)
- Lipidic Profile (HDL-c)(1 year)
- Lipidic Profile (Triglycerides)(1 year)
- Changes of Carotid Intima-media Thickness Over Time(1 year)
研究者
Armando Torres Ramírez
PhD
Fundación Canaria Rafael Clavijo para la Investigación Biomédica