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临床试验/NCT00759369
NCT00759369已完成不适用

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

University of Kansas1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2008年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Percentage of mean urine osmolality decreased from baseline

研究概览

简要总结

Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2). Cysts begin to develop primarily in renal collecting tubules in utero and continue to form and expand throughout the patient's life. One of the goals of the study is to formulate a water prescription for use in clinical trials to determine the effect of sustained water diuresis on the progression of ADPKD.

详细描述

The proposed study will devise a quantitative model to estimate the amount of water an individual would need to ingest in order to lower the 24 h mean urine osmolality to a level below plasma (~285 mOsm/Kg). This osmolality goal is chosen because the 24h median urine osmolality of humans is ordinarily ~753 mOsm/Kg, much greater than 285 mosm/Kg (6, 7). In other words, normal humans are usually anti-diuretic during waking hours and while asleep. Median 24h urine volume is ~1225 ml (range 1051 - 2270). In temperate climates the insensible losses of water in sweat, respiration and stool are nearly balanced by the water ingested in solid and semi-solid foods and derived from metabolism. Thus, daily urine volume measured upon arising in the morning is a reasonably good indicator of the volume of fluids drunk over the preceding 24 h.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ADPKD verified by ultrasound, CT or MRI, family history or physical exam
  • •Normal creatinine clearance, calculated by Cockroft-Gault formulat
  • •Good general health
  • •Controlled blood pressure, < 140/90
  • •Absence of urinary tract symptoms such as dysuria, hesitancy, diminished flow

排除标准

  • •Uncontrolled hypertension
  • •Urinary tract symptoms, dysuria, hesitancy, diminished flow, gross hematuria
  • •Diabetes mellitus, cancer, hematologic disorder
  • •Unable to follow directions
  • •Solitary kidney
  • •History of CHF, liver dysfunction or hyponatremia
  • •Currently taking diuretics
  • •Nephrotic range proteinuria (3.5 g/day)

研究组 & 干预措施

1

Experimental

Water prescription

干预措施: Water prescription (Other)

结局指标

主要结局

Percentage of mean urine osmolality decreased from baseline

时间窗: Day 3, 4, 5

次要结局

  • Number of individuals who have an average daily solute excretion within 16.5% of baseline(End of study)
  • Number of individuals whose average total urine volume is within 18% of baseline.(End of study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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