EUCTR2015-005113-73-NL进行中（未招募）1 期
Rotation for Optimal Targeting of Albuminuria and Treatment Evaluation - ROTATE-2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
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
- •Type 2 diabetes
- •eGFR > 45ml/min/1.73m2
- •Albumin:creatinine ratio >50mg/g and =500 mg/g
- •Age = 18 years
- •Written informed consent
- •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 52
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnant women and women of child-bearing potential who are not using
- •reliable contraception
- •Cardiovascular disease: myocardial infarction, angina pectoris,
- •percutanous transluminal coronary angioplasty, coronary artery bypass
- •grafting, stroke, heart failure (NYHA I-IV) < 6 months before inclusion
- •Uncontrolled blood pressure (office bp > 160/ 100 mmHg)
- •Active malignancy
- •History of autonomic dysfunction (e.g. history of fainting or clinically
- •significant orthostatic hypotension)
- •Participation in any clinical investigation within 3 months prior to initial
- •dosing or longer if required by local regulations, and for any other limitation
- •of participation based on local regulations.
- •Donation or loss of 400 ml or more of blood within 8 weeks prior to initial
- •History of drug or alcohol abuse within the 12 months prior to dosing, or
- •evidence of such abuse as indicated by the laboratory assays conducted during the screening.
- •Any medication, surgical or medical condition which might significantly alter
- •the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
- •oMajor gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
- •oGastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
- •oPancreatic injury or pancreatitis within the last six months;
- •oEvidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at inclusion visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
- •oEvidence of urinary obstruction of difficulty in voiding at screening
研究者
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