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临床试验/EUCTR2021-001247-27-DE
EUCTR2021-001247-27-DE进行中(未招募)1 期

SeMaglutide and Albuminuria Reduction Trial in obese individuals without diabetes - SMART

niversity Medical Center Groningen0 个研究点目标入组 98 人开始时间: 2022年6月27日最近更新:
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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