The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Percent Change in IL-8
研究概览
简要总结
The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
详细描述
In patients with end stage renal disease (ESRD) receiving dialysis, the risk of cardiovascular death has been estimated to be 10-100 times higher than the general population without renal disease. This is due in part to high levels of inflammation and vascular calcification (large deposits of calcium in arteries) found in these patients. Chronic inflammation is particularly common in patients with ESRD. Parenteral iron therapy, which is common in patients on dialysis, may contribute to this inflammation and also a higher cardiovascular risk. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. In a study of 10,044 hemodialysis patients, treatment with a phosphate binder was associated with improved survival. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. It has been shown to improve serum phosphorus levels and decrease intravenous iron requirements for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.
Ferric citrate has the potential to decrease cardiovascular risk through multiple mechanisms:
- acting as a non-calcium based binder to decrease serum phosphorus levels and vascular calcification,
- decreasing intravenous iron requirements which in turn may decrease inflammation,
- binding endotoxin (a harmful substance produced by microorganisms) in the gut and
- improving lipid metabolism.
The purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Hemodialysis treatment for ≥ 6 months
- •Phosphate binder treatment for ≥ to 1 month
- •Maintenance iron therapy with no more than 125mg IV iron weekly≥ to 1 month
- •Serum phosphorus levels between 2.5 and 8 at screening
- •Serum phosphorus ≥ to 6.0 mg/dL after a 2 week washout period.
- •Serum ferritin ≥ 200 and < 600ng/ml after a 2 week washout period
- •Serum calcium levels within normal range
- •Predicted survival greater than 6 months
排除标准
- •Intact PTH< 70 pg/ml or > 1,000 pg/ml
- •Oral iron use
- •Vitamin C supplement use
- •Parathyroidectomy
- •Active malignancy
- •Hemodialysis via an intravenous catheter or arteriovenous (AV) graft
- •Received > 250mg of IV iron over the two weeks prior to screening
- •Whole blood transfusion within 3 months prior to screening
- •Active bleeding other than from the dialysis access
- •Hospitalization within one month prior to screening
- •current infection
- •Ongoing or uncontrolled inflammatory disorder
- •Liver cirrhosis
- •Likelihood of imminent renal transplantation
研究组 & 干预措施
Ferric Citrate
Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.
干预措施: Ferric Citrate (Drug)
结局指标
主要结局
Percent Change in IL-8
时间窗: Baseline, Month 6
Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.
Percent Change in Total Cholesterol
时间窗: Baseline, Month 6
Percent change in total cholesterol (mg/dl) from Baseline to Month 6.
Percent Change in LDL-Cholesterol
时间窗: Baseline, Month 6
Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6
Percent Change in HDL Cholesterol
时间窗: Baseline, Month 6
Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.
Percent Change in Triglycerides
时间窗: Baseline, Month 6
Percent change in triglycerides (mg/dl) from baseline to Month 6.
Percent Change in TNF-alpha
时间窗: Baseline, Month 6
Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.
Percent Change in IL-6
时间窗: Baseline, Month 6
Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6
Percent Change in Ferritin
时间窗: Baseline, Month 6
Percent change in ferritin (ng/ml) from baseline to Month 6.
Percent Change in C-reactive Protein
时间窗: Baseline, Month 6
Percent change in C-reactive Protein (mg/L) from baseline to Month 6.
Percent Change in Homocysteine
时间窗: Baseline, Month 6
Percent change in homocysteine (micromol/L) from baseline to Month 6.
Change in Intravenous Iron Use
时间窗: Baseline, Month 6
Change in intravenous iron use (mg) from Baseline to Month 6.
次要结局
- Percent Change in Calcium(Baseline, Month 6)
- Percent Change in Phosphorus(Baseline, Month 6)
- Percent Change in Parathyroid Hormone (PTH)(Baseline, Month 6)