EUCTR2021-004073-31-NL进行中（未招募）1 期
Treating microalbuminuria over 24 weeks in subjects with or without type 2 diabetes or hypertension
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
- 340
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
- •Age 45 to 80 years
- •Persistent urinary albumin:creatinine ratio (UACR) = 2.5 mg/mmol (~25 mg/g)
- •Willing to sign 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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •Diagnosis of type 1 diabetes mellitus
- •eGFR < 25 ml/min/1.73m2
- •UACR > 3500 mg/g
- •Concurrent treatment with SGLT2 inhibitor
- •Receiving immunosuppressive therapy within 6 months prior to enrolment
- •History of diabetic ketoacidosis
- •Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin.
- •Initiation or changes in the dose of interventions in the renin-angiotensin-aldosterone-system, diuretics, GLP-1 receptor agonists within 6 weeks of screening will not be allowed.
- •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:
- •oHistory of active inflammatory bowel disease within the last six months;
- •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 the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
- •oEvidence of urinary obstruction or difficulty in voiding at screening
- •History of severe hypersensitivity or contraindications to dapagliflozin
- •Subjects who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data
- •Participation in any clinical intervention study within 3 months prior to initial dosing.
- •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.
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- •Pregnancy or breastfeeding
研究者
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