High Water Intake to Slow Progression of Polycystic Kidney Disease

NCT ID: NCT00784030

Last Updated: 2016-04-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney, Polycystic, Autosomal Dominant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Polycystic Kidney Disease Patients

Patients who present with polycystic kidney disease (PKD)

Group Type OTHER

Water

Intervention Type OTHER

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

Group Type OTHER

Water

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irina Barash, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Langone Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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08-774

Identifier Type: -

Identifier Source: org_study_id

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