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High Water Intake to Slow Progression of Polycystic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00784030
Recruitment Status : Completed
First Posted : November 3, 2008
Results First Posted : April 6, 2016
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney, Polycystic, Autosomal Dominant Other: Water Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Water Loading on Urinary Biomarkers
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Polycystic Kidney Disease Patients
Patients who present with polycystic kidney disease (PKD)
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.
Healthy Patients 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.



Primary Outcome Measures :
  1. Change in Urine cAMP Concentration and Urine Osmolality (UOsm) [ Time Frame: pre- and post-water loading (2 hours) ]
    Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784030


Locations
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Irina Barash, M.D. New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00784030     History of Changes
Other Study ID Numbers: 08-774
First Posted: November 3, 2008    Key Record Dates
Results First Posted: April 6, 2016
Last Update Posted: April 6, 2016
Last Verified: March 2016

Keywords provided by New York University School of Medicine:
Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney Disease
Water Loading
Biomarkers

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn