Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percent changes in FGF-23
研究概览
简要总结
Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently identified phosphaturic hormone that has been reported to be associated with the development of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.
While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased FGF-23 levels have been reported with vitamin D administration. The purpose of this study was to investigate the effect of calcium carbonate when used in conjunction with calcitriol on FGF-23.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of 18~70 years of age
- •CKD stage 3 patients (GFR: 30-60ml/min/1.73m2)
- •Patients who've given consent to the trial
排除标准
- •Known allergy to Vitamin D or calcium carbonate
- •Administration of vitamin D analogue or phosphate binders 3 months prior to study entry
- •History of hypercalcemia (corrected serum calcium > 10.5 mg/dL) or hypophosphatemia (serum phosphate < 2.5 mg/dL) 3 months prior to study entry
- •Patients with bone pathologies or diseases requiring vitamin D therapy that is unrelated to CKD-MBD
- •Administration of concurrent medication , diseases, or history of surgeries that may affect bone-mineral metabolism or alter bone status
- •Patients diagnosed with rapidly progressive glomerulonephritis(RPGN) or those in need of renal replacement therapy
- •Patients with obstructive bowel diseases, or severe gastrointestinal diseases
- •Patients with less than 2 years of life expectancy(ex. Malignancy diseases)
研究组 & 干预措施
Calcitriol
Calcitriol 0.25mcg 1cap daily for 8 weeks
干预措施: Calcitriol (Drug)
Calcitriol + CaCO3
Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
干预措施: Calcitriol (Drug)
Calcitriol + CaCO3
Calcitriol 0.25mcg 1cap daily for 8 weeks, and Calcium Carbonate 500mg 1tab 3 times daily for 8 weeks
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
Percent changes in FGF-23
时间窗: 8 weeks after administration
Comparison of percent changes in FGF-23 from baseline
次要结局
- Percent changes in Ca(8 weeks after administration)
- Percent changes in P(8 weeks after administration)
- Percent changes in iPTH(8 weeks after administration)
- Percent changes in 25(OH)D(8 weeks after administration)
- Percent changes in 1,25(OH)2D(8 weeks after administration)
研究者
Yon Su Kim
Professor
Seoul National University Hospital