The Efficacy and Safety of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 1,508
- 试验地点
- 7
- 主要终点
- macroalbuminuria and serum creatinine
研究概览
简要总结
The purpose of this study is to determine the effect and safety of Sulodexide in Filipino patients with Chronic Kidney Disease (CKD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •positive 2 of 3 ACR > 300 mg/g or 24h urine protein or albumin collection > 300 mg/d in the absence of urinary tract infection
- •serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men
排除标准
- •age of onset of DM \< 18 years
- •+ renal disease like non-DM renal disease
- •+ CV diseases such as UA, MI, CABG
- •+ CVA or TIA within last 6 months
- •untreated UTI
研究组 & 干预措施
placebo gelcaps + best medical treatment
Patient will receive 4 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
干预措施: placebo capsules (Drug)
SLX 500LRU/day + best medical treatment
Patient will receive 1 SLX gelcap and 3 placebo gelcaps twice a day.Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
干预措施: Sulodexide (Drug)
SLX 1000LRU/day + best medical treatment
Patient will receive 2 SLX gelcaps and 2 placebo gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
干预措施: Sulodexide (Drug)
SLX 2000LRU/day + best medical treatment
Patient will receive 4 SLX gelcaps twice a day. Best Medical Treatment (BMT)refers to the treatment currently acceptable and standard measures for the decrease in proteinuria. These are strict blood sugar control (HBA1c < 7.0%) and BP control (BP< 130/80)
干预措施: Sulodexide (Drug)
结局指标
主要结局
macroalbuminuria and serum creatinine
时间窗: 52 weeks
次要结局
- adverse events(52 weeks)