EUCTR2021-001247-27-DE进行中(未招募)1 期
SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes - SMART
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Age = 18 years
- •Body Mass index = 27 kg/m2
- •Albuminuria = 30 mg/g and = 3500 mg/g
- •eGFR = 25 ml/min/1.73m2
- •Stable renal function prior to entry into the study defined as no more than 30% eGFR change in 3
- •months prior to enrolment
- •Signed 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 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Diagnosis with type 1 or type 2 Diabetes
- •Hba1c = 6.5% at screening
- •Cardiovascular disease event in 3 months prior to enrollment
- •Treatment with GLP-1 RA < 4 weeks prior to screening
- •Uncontrolled thyroid disease TSH>6.0 mIU/L or <0.4 mIU/L at screening
- •Acute pancreatitis < 180 days prior to screening
- •History or presence of chronic pancreatitis
- •Females of child-bearing potential who are pregnant, breast-feeding or have intention of
- •becoming pregnant or are not using adequate contraceptive measures
研究者
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