High Water Intake to Slow Progression of Polycystic Kidney Disease

Kidney, Polycystic, Autosomal Dominant Clinical Trial

Official title:

The Effect of Water Loading on Urinary Biomarkers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00784030
• Other study ID #: 08-774
• Status: Active, not recruiting
• Phase: N/A
• First received: October 31, 2008
• Last updated: July 10, 2009
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2009
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney, Polycystic, Autosomal Dominant
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary biomarkers		One week	No