A Randomized Study on the Effects of Sevelamer Carbonate Versus Calcium Acetate on Biomarkers of Vascular Calcification, Inflammation, and Endothelial Dysfunction in Chronic Kidney Disease Stages 3 and 4
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be the change in FGF-23 concentrations
研究概览
简要总结
Chronic kidney disease (CKD) patients often have high levels of a substance called fibroblast growth factor-23 (FGF-23), a phosphorus excreting hormone, which has been related to heart disease. As kidney function declines, less phosphorus is removed by the kidneys and as a result phosphorus accumulates in the blood. In response to elevated phosphorus levels, more FGF-23 is released to help facilitate the excretion of extra phosphorus into the urine. In addition to effects on FGF-23, increased phosphorus levels can lead to calcification (hardening) of the blood vessels in the CKD population.
Phosphate binding medicines are used in CKD patients to lower the amount of phosphorus absorbed by the stomach and intestines after eating meals and snacks. In patients with CKD, studies have shown that phosphate binders can lower FGF-23 levels in the blood. Lowering FGF-23 levels in CKD patients may also lower substances in the blood that cause calcification of blood vessels in the CKD population.
This study is being done to determine if using phosphate binders, either sevelamer carbonate or calcium acetate, in the earlier stages kidney disease (before dialysis) can decrease FGF-23 and biomarkers (substances in the blood) associated with hardening of the blood vessels and heart disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 18 years of age at start of screening
- •CKD stage 3 or 4 defined by an eGFR 15 - 60 mL/min/1.73m2
- •Not expected to start dialysis for 8 months
- •Serum intact PTH < 500 pg/mL during screening period
- •On a stable ACE inhibitor/ARB regimen for 30 days prior to screening
排除标准
- •History of any of the following diseases: congestive heart failure, MI within the last 6 months, cerebrovascular accident, significant valvular disease, malignancy
- •Currently receiving erythropoiesis stimulating agent or IV iron therapy
- •History of inflammatory/autoimmune disease
- •History of polycystic kidney disease
- •HIV positive or AIDS
- •Pregnant or breastfeeding
- •Receiving activated Vitamin D analogs, nutritional vitamin D agents > 2,000 IU/day, or calcimimetics with in the last 3 months
- •Significant GI disorder
- •Proteinuria >3.5 g/24 hours
研究组 & 干预措施
Sevelamer carbonate
1,600 mg (2 x 800 mg) three times daily with meals for a total of 12 weeks
干预措施: Sevelamer carbonate (Drug)
Calcium acetate
1,334 mg (2 x 667 mg) three times daily with meals for a total of 12 weeks
干预措施: Calcium acetate (Drug)
结局指标
主要结局
The primary outcome measure will be the change in FGF-23 concentrations
时间窗: 12 weeks
次要结局
- Change in vascular calcification biomarker levels(12 weeks)
- Change in endothelial dysfunction biomarker levels.(12 Weeks)
- Change in inflammatory biomarker levels(12 Weeks)
研究者
Darius Mason
PI
Albany College of Pharmacy and Health Sciences