NCT01231438已完成2 期
An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- FGF23 serum level
研究概览
简要总结
Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Renal failure stage 3B
- •25(OH)vitamin D level above 50 nmol/l
- •Age over 18 years
- •Written consent
排除标准
- •Major surgery during the previous 6 months
- •Myocardial infarct during the previous 6 months
- •Unstable heart failure
- •Ongoing treatment for any malignancy
- •History of frequent infections
- •Pregnancy
- •Ongoing treatment with steroids, lithium or biphosphonates
研究组 & 干预措施
Renvela
Experimental
Treatment for 2 weeks
干预措施: Renvela (Drug)
Etalpha
Experimental
Vit D Treatment for 2 weeks
干预措施: Etalpha (Drug)
结局指标
主要结局
FGF23 serum level
时间窗: Change over 2 weeks of treatment
次要结局
- Calcium serum level(Change over 2 weeks of therapy)
- Phosphate serum level(Change over 2 weeks of therapy)
- CTX-1 serum level(Change over 2 weeks of therapy)
- PINP serum level(Change over 2 weeks of therapy)
- PTH serum level(Change over 2 weeks of therapy)
研究者
研究点 (2)
Loading locations...
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