Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of participants who complete all study procedures
研究概览
简要总结
The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:
- Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?
- Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?
Participants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.
Study Procedures Include
- For participants randomly selected for treatment, take empagliflozin once daily for 3 months
- Phone calls with researchers every 2 weeks for check-ins
- For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests
- All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2
排除标准
- •Heart Disease
- •Pregnancy
- •Recipient of solid organ transplant
- •history of chemotherapy or stem cell transplant
- •moderate to severe persistent asthma
- •liver disease
- •class 2 or greater obesity
- •inability to follow study procedures due to cognitive impairment
- •obstructive uropathy or requirement for intermittent urinary catheterization
- •systolic blood pressure <100mgHg
- •orthostatic hypotension
- •current use of an SGLT2i
- •anticipated need for titration of anti-hypertensives within 3 months
- •active use of any immunosuppressive medications
- •lack of clearance by primary nephrologist for participation
研究组 & 干预措施
Treatment
Empagliflozin 10mg daily for 3 months (n=20)
干预措施: Empagliflozin 10 MG (Drug)
Standard of Care
Participants will not take empagliflozin (n=20)
结局指标
主要结局
Percentage of participants who complete all study procedures
时间窗: 4 years
Compared to the number recruited, how many participants complete the study
次要结局
- Systolic Blood Pressure(3 months)
- Urine Albumin to Creatinine Ratio (UACr)(3 months)
- Left Atrial Reservoir Strain(3 months)
- Serum N-terminal pro-brain natruetic peptide (NT-proBNP)(3 months)
研究者
Alexander Kula
Assistant Professor of Pediatrics (Nephrology)
Ann & Robert H Lurie Children's Hospital of Chicago