The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
研究概览
简要总结
The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).
Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.
详细描述
This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.
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
- Double (Participant, Investigator)
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 and non-pregnant females ages 18 years of age or older
- •Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m
- •Serum phosphate > 3.5 mg/dL
- •Fibroblast growth factor 2 (FGF2) > 100 relative units per milliliter (RU/mL)
- •Corrected serum calcium >8.0mg/dL
排除标准
- •Current use of a phosphate binder
- •Corrected serum calcium <8.0mg/dL
- •Current use of prescription-based vitamin D therapy
- •Acute kidney injury in last 3 months
- •Significant GI disorder
- •History of allergic reaction or sensitivity to lanthanum carbonate
- •History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator
- •Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
研究组 & 干预措施
Lanthanum Carbonate (Fosrenol)
Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)
干预措施: Lanthanum Carbonate (Fosrenol) (Drug)
Placebo
Subject will receive placebo
干预措施: placebo (Drug)
结局指标
主要结局
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
时间窗: Baseline, 60 days
Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days
次要结局
- 25 Hydroxyvitamin D Mean Change From Baseline(Baseline, 60 days)
- 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline(Baseline, 60 days)
- Calcium Mean Change From Baseline(Baseline, 60 days)
- Serum Phosphate Mean Change From Baseline(Baseline, 60 days)
- Serum Alkaline Phosphatase Mean Change From Baseline(Baseline, 60 days)
- Serum Osteocalcin Mean Change From Baseline(Baseline, 60 days)
- Change From Baseline Serum Parathyroid Hormone(Baseline, 60 days)
- 24 Hour Urine Phosphate Mean Change From Baseline(Baseline, 60 days)
研究者
Stuart Sprague
Chief, Division of Nephrology and Hypertension Professor of Medicine University of Chicago Medical School
NorthShore University HealthSystem