EUCTR2009-016531-35-FR进行中（未招募）1 期
A Proof of Concept, Phase 2a, Double-blind, Parallel Group, Randomised, Placebo controlled Study to Assess the Effect of Lanthanum Carbonate on intact FGF23 in Normo-phosphataemic Subjects with Stage 3 Chronic Kidney Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female subjects =18 years old, who have been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months
- •2) Screening c-terminal FGF23 > 50RU/mL
- •3) Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the formula derived from the Modification of Diet in Renal Disease (MDRD)
- •4) Screening normal serum phosphate (0.808-1.55mmol/L) and endogenous 25-hydroxy Vitamin D levels >20ng/mL
- •5) Adequate protein diet (includes 2-3 portions of protein rich food per day).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Subjects who require Vitamin D supplementation, or compounds containing calcium, phosphate, aluminium or magnesium, subjects with acute renal failure, and subjects with rapidly progressing glomerulonephritis
- •2) Vegetarian diet
- •3) Known allergy to iodine.
研究者
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