High Water Intake to Slow Progression of Polycystic Kidney Disease

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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Key information

Conditions

Kidney, Polycystic, Autosomal Dominant Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

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.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

The Effect of Water Loading on Urinary Biomarkers

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 3, 2008
Registry last updated: Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed