NCT07084038进行中（未招募）不适用
Effect of Glycosuria on Urinary Protein in Patients With Chronic Kidney Disease Treated With SGLT2 Inhibitor
Yuanjun Yang1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up
研究概览
简要总结
This trial aims to investigate the correlation between glycosuria levels and urinary protein in chronic kidney disease patients treated with Sodium-Glucose Transporter 2 Inhibitors(SGLT2i), and to explore whether glycosuria can reflect the therapeutic response to SGLT2i in these patients. Through this study, the investigators hope to provide some clinical references for optimizing SGLT2i dosing strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years. Patients with a confirmed diagnosis of chronic kidney disease (CKD). Currently receiving stable, standard-dose SGLT2i therapy at screening. Proteinuria ≥0.15 g/24 h (or urine protein-to-creatinine ratio [UPCR] ≥440 mg/g or urine albumin-to-creatinine ratio [UACR] ≥300 mg/g) at screening.
- •Estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73m² calculated by the CKD-EPI creatinine equation at screening.
- •Willing and able to provide written informed consent.
排除标准
- •Discontinuation of SGLT2i during the follow-up period. History of symptomatic hypotension (systolic blood pressure<90 mmHg) without antihypertensive medication, or current hypotensive episode at screening.
- •Unstable renal function (e.g., acute kidney injury or rapidly progressive glomerulonephritis with a >50% decline in eGFR within 3 months prior to screening).
- •Use of corticosteroids or having an indication for corticosteroid therapy within the past 6 months.
- •Receipt of immunosuppressive therapy or having an indication for immunosuppressive therapy within the past 6 months.
- •History of intolerance to SGLT2 inhibitors. History of ketoacidosis within the past 5 years.
结局指标
主要结局
The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up
时间窗: 3 months and 6 months
The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up
次要结局
- The proportion of a 50% reduction in urinary protein, the proportion of a 30% reduction in urinary protein, and the changes in estimated glomerular filtration rate (eGFR)(3 months and 6 months)
研究者
Yuanjun Yang
Principal Investigator
Chinese PLA General Hospital
研究点 (1)
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