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High Water Intake to Slow Progression of Polycystic Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by New York University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00784030
First received: October 31, 2008
Last updated: July 10, 2009
Last verified: July 2009
History of Changes

October 31, 2008
July 10, 2009
November 2008
November 2009   (final data collection date for primary outcome measure)
Change in urinary biomarkers [ Time Frame: One week ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00784030 on ClinicalTrials.gov Archive Site
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High Water Intake to Slow Progression of Polycystic Kidney Disease
The Effect of Water Loading on Urinary Biomarkers

Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.
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Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Kidney, Polycystic, Autosomal Dominant
Other: Water
Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI
  • Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI
  • Ages between 18 and 65
  • Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) > 60 ml/min/1.73 m2 with no history of kidney disease

Exclusion Criteria:

  • Women who are pregnant or nursing
  • Active dependency on drugs or alcohol
  • Diagnosis of syndrome of inappropriate antidiuresis
  • Currently taking a vasopressin agonist or antagonist
  • Blood sodium level less than < 135 mEq/L
  • For healthy participants, estimated glomerular filtration rate (level of kidney function) less than < 60 ml/min/1.73 m2
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00784030
08-774
No
Irina Barash/ M.D., New York University School of Medicine
New York University School of Medicine
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Principal Investigator: Irina Barash, M.D. New York University School of Medicine
New York University School of Medicine
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP