jRCT2080224766已完成3 期
Effect of semaglutide versus placebo on the progression of renal impairment in subjects with type 2 diabetes and chronic kidney disease (FLOW)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,508
- 试验地点
- 1
- 主要终点
- Time to first occurrence of a composite endpoint
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized Controlled Trial, Double Blind, Placebo Control, Parallel Assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial, except for protocol described pre-screening activities which require a separate informed consent.
- •Male or female, age above or equal to 20 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus.
- •HbA1c <=10% (<= 86 mmol/mol).
- •Renal impairment defined either by:
- •a. serum creatinine-based eGFR >= 50 and <= 75mL/min/1.73 m2(CKD-EPI), and UACR > 300 and < 5000 mg/g.
- •b. serum creatinine-based eGFR >= 25 and < 50 mL/min/1.73 m2(CKD-EPI)* and UACR > 100 and < 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 inclusion criterion 5 and kept stable until screening.
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Previous participation in this trial. Participation is defined as randomisation.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- •Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. Brazil: For country specific requirements.
- •Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- •Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.
- •Use of any GLP-1 receptor agonist within 30 days prior to screening.
- •Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC).
- •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.
- •Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
- •A prior solid organ transplant or awaiting solid organ transplant.
- •Combination use of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin II receptor blocker (ARB).
结局指标
主要结局
Time to first occurrence of a composite endpoint
Composite endpoint consisting of: - Onset of persistent >= 50% reduction in eGFR (CKD-EPI) compared with baseline - Onset of persistent eGFR (CKD-EPI) <15 mL/min/1.73 m2 - Initiation of chronic renal replacement therapy (dialysis or kidney transplantation) - Renal death - CV death
次要结局
未报告次要终点
研究者
研究点 (1)
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