Overview

This trial is active, not recruiting.

Condition kidney, polycystic, autosomal dominant
Treatment water
Sponsor New York University School of Medicine
Start date November 2008
End date November 2009
Trial size 20 participants
Trial identifier NCT00784030, 08-774

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose basic science

Primary Outcomes

Measure
Change in urinary biomarkers
time frame: One week

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title The Effect of Water Loading on Urinary Biomarkers
Principal investigator Irina Barash, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by New York University School of Medicine.