Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease - FLOW

ovo Nordisk A/S0 个研究点目标入组 3,160 人开始时间: 2019年1月17日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•- Male or female, age 18 years or older at the time of signing informed consent. Japan: 20 years.
•- Diagnosed with type 2 diabetes mellitus
•- HbA1c (glycated haemoglobin) equal to or below 10% (equal to or below 86 mmol/mol)
•- Renal impairment defined either by:
•a) serum creatinine-based eGFR (estimated glomerular filtration rate) equal to or above 50 and equal to or below 75 mL/min/1.73 m^2 (chronic kidney disease - epidemiology collaboration, CKD-EPI) and UACR (urinary albumin-to-creatinine ratio) above 300 and below 5000 mg/g
•b) serum creatinine-based eGFR equal to or above 25 and below 50 mL/min/1.73 m^2 (CKD-EPI) and UACR above 100 and below 5000 mg/g
•- Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone
•system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.
•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 1896
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1264

•- Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations
•- Use of any glucagon-like peptide-1 (GLP-1) receptor agonist within 30 days prior to screening
•- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening
•- Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
•- Planned coronary, carotid or peripheral artery revascularisation
•- Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis
•- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

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