NCT02644486终止不适用
A Prospective, Single-center, Randomized, Controlled Study of Sevelamer Carbonate in the Lipid Metabolism and Uric Acid Treatment of Obesity-Related Glomerulopathy
Zhi-Hong Liu, M.D.1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- low-density lipoprotein
研究概览
简要总结
To observe the decreased levels of low-density lipoprotein from baseline in patients with obesity-related glomerulopathy (ORG) after 12 weeks of Sevelamer Carbonate treatment.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of obesity
- •diagnosed ORG by renal biopsy
- •LDL>3.37mmol/L
- •Proteinuria 0.5-3.5g/d
- •eGFR (CKD-EPI formula) > 30ml/min
排除标准
- •Other concomitant renal diseases
- •Endocrine or drug-induced obesity;
- •Type 2 diabetes
- •eyes or obvious microscopic hematuria;
- •Swallowing difficulty / severe gastrointestinal dysfunction
- •intestinal obstruction;
- •severe arrhythmia;
- •Hypophosphatemia (<0.7mmol/L);
- •allergic to Sevelamer Carbonate
- •unable to well cooperate
- •Females who are in the period of gestation or lactation, or refuse to use contraception;
- •participated in other clinical trial of drug within three months
研究组 & 干预措施
A Group
Experimental
干预措施: High dosage Sevelamer Carbonate + Irbesartan (Drug)
B Group
Experimental
干预措施: Low dosage Sevelamer Carbonate + Irbesartan (Drug)
C Group
Active Comparator
干预措施: Irbesartan (Drug)
结局指标
主要结局
low-density lipoprotein
时间窗: 12 weeks
decreased levels of low-density lipoprotein from baseline
次要结局
- uric acid(12 weeks)
- blood glucose(12 weeks)
- blood lipids parameters (CHO, TG, HDL)(12 weeks)
- proteinuria(12 weeks)
- glycated hemoglobin(12 weeks)
研究者
Zhi-Hong Liu, M.D.
professor
Nanjing University School of Medicine
研究点 (1)
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