Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
研究概览
简要总结
Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of progression of CKD and predict mortality in CKD. Although studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been reported. Our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will also be investigating associations of elevation in FGF 23 levels with commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and Hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between ages 18-80 years old, with a GFR less than or equal to 50 ml/min/1.73 m2 as determined by the Modification of Diet in Renal Disease (MDRD) formula will be included.
排除标准
- •Patients will be excluded if they have a history of renal transplant or are pregnant. In addition, patients with dysphagia, swallowing disorders, severe GI motility disorders, severe constipation, history of major gastrointestinal surgery and patients taking levothyroxine for hypothyroidism will be excluded.
研究组 & 干预措施
Treatment
Patients enrolled will receive Renvela for a 3 month time frame.
干预措施: Sevelamer Carbonate (Drug)
结局指标
主要结局
Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
时间窗: March 2011-June 2012
Determine if phosphate reduction through the use of non-calcium based phosphate binders will decrease serum FGF23 levels
次要结局
未报告次要终点