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

First Received on October 31, 2008. Last Updated on July 10, 2009 History of Changes

Sponsor:	New York University School of Medicine
Information provided by:	New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00784030

Purpose

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	Intervention
Kidney, Polycystic, Autosomal Dominant	Other: Water

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	The Effect of Water Loading on Urinary Biomarkers

Resource links provided by NLM:

Genetics Home Reference related topics: polycystic kidney disease

U.S. FDA Resources

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

Change in urinary biomarkers [ Time Frame: One week ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Additional Information:

NYU Polycystic Kidney Disease center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Irina Barash/ M.D., New York University School of Medicine
ClinicalTrials.gov Identifier:	NCT00784030 History of Changes
Other Study ID Numbers:	08-774
Study First Received:	October 31, 2008
Last Updated:	July 10, 2009
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 09, 2012