EUCTR2012-000451-13-DK进行中（未招募）1 期
A controlled randomized, open-label, multi-centre study evaluating if a steroid-free immunosuppressive protocol, based on ATG- induction, low tacrolimus-dose and therapeutic drug monitoring of mycophenolate mofetil, reduces the incidence of new onset diabetes after transplantation, in comparison with a standard steroid-based protocol with low-dose tacrolimus. - SAILOR
Per Lindner0 个研究点目标入组 200 人开始时间: 2013年8月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients receiving a first or second single kidney transplant from a deceased or a living donor.
- •2.Female or male aged above 18 years.
- •3.Patients considered for a standard immunosuppressive protocol.
- •4.Patients capable of giving written informed consent for participation in the study for 24 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Patients with known diabetes mellitus or plasma glucose >11.1 mmol/l at admission
- •2.Patients receiving steroids at the time of transplantation or likely to need steroids after transplantation
- •3.Recipients of multiorgan transplants, and or previously transplanted with any other organ than kidney
- •4.Patients with CDC-PRA > 25 % in most recent test or for any other reason considered to be of a high risk for rejection which requires an enhanced immunosuppression.
- •5.Patients receiving a renal transplant from a HLA-identical sibling
- •6.Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study
- •7.Patients who are recipients of ABO-incompatible transplants
- •8.Patients who are unlikely to comply with the study requirements
- •9.Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.
- •10.Females of childbearing potential, who are, or are planning to be, pregnant, and/or are unwilling to use effective means of contraception.
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