Use of Sevelamer Hydrochloride to Control Hyperphosphatemia and Reduce Calcification Burden in the Poor Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in coronary artery, aortic valve, mitral annulus calcium scores
研究概览
简要总结
To test the hypothesis that second-line fixed low-dose sevelamer hydrochloride therapy is as effective as first-line high-dose sevelamer hydrochloride therapy in limiting the progression of cardiovascular calcification.
详细描述
Cardiovascular disease accounts for nearly 50% of the mortality and is the most frequent cause of hospitalization in ESRD patients. Hyperphosphatemia is increasingly recognized to be an important predictor of mortality and cardiovascular death in ESRD patients and is largely attributed to the increased prevalence of vascular calcification.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESRD patients receiving long-term peritoneal dialysis treatment with hyperphosphatemia currently receiving aluminum-based phosphorus binders or whose phosphorus control remains suboptimal with calcium-based binders only
- •Patients who cannot afford to self-pay sevelamer hydrochloride.
- •Patients who provided informed consent for the study
排除标准
- •Patients with underlying active malignancy
- •Patients with cyanotic congenital heart disease
- •Patients with poor general condition
- •Patients with plan for living related kidney transplant within coming 1 year
- •Female patients with pregnancy
研究组 & 干预措施
higher dose sevelamer
first-line higher dose sevelamer hydrochloride
干预措施: sevelamer hydrochloride (Drug)
low dose sevelamer
second-line fixed low-dose sevelamer hydrochloride added to calcium carbonate
干预措施: sevelamer hydrochloride (Drug)
结局指标
主要结局
Changes in coronary artery, aortic valve, mitral annulus calcium scores
时间窗: over 24 months
Vascular and valvular calcium scores
次要结局
- Changes in aortic pulse wave velocity(over 24 months)
- annualized percentage change in Coronary artery calcium score(over 12 months)
- Changess in serum T50(over 24 months)
- Changes in serum calcium, phosphate(over 24 months)
- Changes in alkaline phosphatase(over 24 months)
- Changes in intact parathyroid hormone(over 24 months)
- Changes in low density lipoprotein-cholesterol(over 24 months)
- Changes in C-reactive protein(over 24 months)
- Changes in systolic blood pressure(over 24 months)
- Changes in diastolic blood pressure(over 24 months)
- Changes in Forearm, femur and spine bone mineral density, T score and Z score(over 24 months)
研究者
Dr. Angela Yee-Moon Wang
Dr.
The University of Hong Kong