跳至主要内容
临床试验/NCT01231438
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.

Helse Stavanger HF2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2010年10月最近更新:
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

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

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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