A Controlled Randomized, Open-label, Multi-centre Study Evaluating if a Steroid-free Immunosuppressive Protocol, Based ATG-induction, Low Tacrolimus-dose and Therapeutic Drug Monitoring of Mycophenolate Mofetil, Reduces the Incidence of New Onset Diabetes After Transplantations, in Comparison With Standard Steroid-based Protocol With Low-dose Tacrolimus.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
研究概览
简要总结
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.
The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.
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
- •First or second single kidney (cadaveric or living donors) transplant recipients.
- •Considered for a standard immunosuppressive protocol.
- •Must be capable of giving written informed connect for participation in the study for 24 months.
排除标准
- •Diabetes mellitus or plasma glucose >11,1 at admission.
- •Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
- •Multiorgan transplants and/or previously transplanted with any other organ than kidney.
- •Panel reacting antibodies(PRA) >25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
- •Renal transplants from HLA-identical sibling.
- •Hypersensitivity to, or disability to take immunosuppressive drugs.
- •Blood group(ABO)-incompatible transplants.
- •Unlikely to comply with the study requirements.
- •Transplant from donor positive for HIV, HBsAg, Hepatitis C.
- •Female of childbearing potential planing/being pregnant or unwilling to use contraception.
结局指标
主要结局
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)
时间窗: 12 month after transplantation
次要结局
- Cumulative incidence of NODAT(3, 6, 24 month after transplantation)
- Incidence of hypertension(3, 12, 24 months)
- Cumulative frequency of infections(10 days, 3, 6, 12, 24 months)
- Composite measure(12, 24 months)
- Antihypertensive treatment(3, 12, 24 months)
- Renal function(12, 24 months)
- Incidence of acute rejection and chronic changes(12 months)
- Lipid lowering drugs(12, 24 months)
- Incidence of antibody-mediated rejection(12, 24 months)
- Cumulative frequency of cardiovascular complications and events.(10 days, 3, 12, 24 months)
- Cumulative frequency of malignancy.(6, 12, 24 months)