High Water Intake to Slow Progression of Polycystic Kidney Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

October 31, 2008

Last Updated Date

July 10, 2009

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00784030 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

High Water Intake to Slow Progression of Polycystic Kidney Disease

Official Title ^ICMJE

The Effect of Water Loading on Urinary Biomarkers

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Kidney, Polycystic, Autosomal Dominant

Intervention ^ICMJE

Other: Water

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00784030

Responsible Party

Irina Barash/ M.D., New York University School of Medicine

Study ID Numbers ^ICMJE

08-774

Study Sponsor ^ICMJE

New York University School of Medicine

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Irina Barash, M.D.

New York University School of Medicine

Information Provided By

New York University School of Medicine

Verification Date

July 2009

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