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临床试验/NCT01163162
NCT01163162已完成4 期

The Effect of Paricalcitol on Creatinine Filtration, Secretion and Glomerular Filtration Rate

Indiana University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
16
试验地点
1
主要终点
24-hour Urine Creatinine Excretion Rate

研究概览

简要总结

The purpose of this study is to study the effects of Paricalcitol (Zemplar) on kidney functioning. The investigators hypothesize that the increase in serum creatinine observed in recent paricalcitol trials is a function of reduced creatinine secretion and not an actual reduction in kidney function. 16 patients will have kidney function measured via iothalamate clearance at baseline, after 7 days of paricalcitol treatment and after 7 days of being washed off the paricalcitol.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Age > 18 years
  • Stage 3 or 4 CKD
  • Ability to give informed consent

排除标准

  • Serum Calcium > 10 g/dL
  • Serum Phosphorous > 6 g/dL
  • On > 400 units/d Vitamin D therapy
  • Receiving cimetidine, triamterene, or trimethoprim, drugs that block creatinine secretion
  • On vitamin D receptor activators (paricalcitol, calcitriol or Zemplar)
  • Allergic to radiocontrast dye

研究组 & 干预措施

Paricalcitol

Experimental

After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.

干预措施: Paricalcitol (Drug)

结局指标

主要结局

24-hour Urine Creatinine Excretion Rate

时间窗: 1 Week

We expect the 24 hour urine creatinine excretion rate to show no differences between groups.

次要结局

  • Creatinine Clearance(1 Week)
  • Serum Creatinine(1 Week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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