NCT06417320招募中4 期
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Protein free period, eGFR
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of ACE inhibitors and SGLT-2 inhibitors on:
- Proteinuria
- Renal survival indices
详细描述
This is a randomized, double blind study. Patients are randomized to receive oral ACE inhibitors or combined ACEI and SGLT-2inhibitrs once daily for12 weeks.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 10 and 18 years old,
- •Nephrotic resistant patients,
- •No history of diabetes,
- •Estimated GFR≥60ml/min/1.73m2, will be evaluated by Schwartz formula,
- •Caregivers' acceptance to be enrolled in the study.
排除标准
- •Uncontrolled urinary tract infection at screening,
- •Blood pressure is less than 5th percentile of the same gender, age, height,
- •At risk of dehydration or volume depletion,
- •Evidence of liver disease: defined by serum levels of alanine transaminase or aspartate transaminase >2 times the upper limit of normal during screening,
- •History of organ transplantation, cancer, liver disease,
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
研究组 & 干预措施
Group 1
Active Comparator
Group 1 (ACEI group)
干预措施: ACEI, SGLT-2i (Drug)
Group 2
Active Comparator
Group 2 (combined ACEI and SGLT-2i group)
干预措施: ACEI, SGLT-2i (Drug)
结局指标
主要结局
Protein free period, eGFR
时间窗: 12 weeks following end of treatment
Protein free period by test strips (dipstick) and microscopy, urine protein/creatinine ratio and Estimated GFR will be evaluated by Schwartz formula
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Sodium Glucose Cotransporter-2 Inhibitors and Salt-sensitivity in Type 2 DiabetesBlood PressureDiabete Type 2Excess SaltNCT06007157Azienda Ospedaliero, Universitaria Pisana30
已完成
2 期
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility StudyCardiorenal SyndromeNCT06111768Yale University30
招募中
不适用
SGLT2 Inhibitor for Severe Tricuspid RegurgitationTricuspid RegurgitationNCT05686616Samsung Medical Center72
招募中
2 期
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMIHeart AttackEnlarged HeartNCT05305911Minneapolis Heart Institute Foundation81
招募中
不适用
Efficacy of SGLT2 Inhibitors in Adults with SepsisInflammationSGLT2 InhibitorsCritically IllOrgan Dysfunction SyndromeSepsisNCT06473844Hospital Authority, Hong Kong60