EUCTR2012-000225-51-AT进行中（未招募）1 期
Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients - ITP-NODAT
Medizinische Universität Wien Universitätsklinik für Innere Medizin III0 个研究点目标入组 380 人开始时间: 2012年11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
- 380
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.Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.
- •2.Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose < 126 mg/dl).
- •3.Receiving standard triple immunosuppressive medications that include tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids.
- •4.Capable of understanding the study and willing to give informed written consent for study participation.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •1.Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dl on two occasions at least three days apart.
- •2.Patients receiving an organ transplant other than kidney.
- •3.Patients receiving an unlicensed drug or therapy within one month prior to study entry.
- •4.Patients with history of hypersensitivity to injectable insulin.
- •5.Patients with documented HIV infection.
研究者
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PRODIG : Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early post-transplant periodrenal transplantMedDRA version: 20.0Level: SOCClassification code: 10038359Term: Renal and urinary disorders Class: 18CTIS2024-516272-14-00Centre Hospitalier Regional Universitaire186
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