Back to resultsHigh Water Intake to Slow Progression of Polycystic Kidney Disease
Primary Purpose
Kidney, Polycystic, Autosomal Dominant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water
Sponsored by
About this trial
This is an interventional basic science trial for Kidney, Polycystic, Autosomal Dominant focused on measuring Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, Water Loading, Biomarkers
Eligibility Criteria
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
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Polycystic Kidney Disease Patients
Healthy Patients
Arm Description
Patients who present with polycystic kidney disease (PKD)
Outcomes
Primary Outcome Measures
Change in Urine cAMP Concentration and Urine Osmolality (UOsm)
Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00784030
Brief Title
High Water Intake to Slow Progression of Polycystic Kidney Disease
Official Title
The Effect of Water Loading on Urinary Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney, Polycystic, Autosomal Dominant
Keywords
Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, Water Loading, Biomarkers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polycystic Kidney Disease Patients
Arm Type
Other
Arm Description
Patients who present with polycystic kidney disease (PKD)
Arm Title
Healthy Patients
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
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 Outcome Measure Information:
Title
Change in Urine cAMP Concentration and Urine Osmolality (UOsm)
Description
Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours
Time Frame
pre- and post-water loading (2 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina Barash, M.D.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
High Water Intake to Slow Progression of Polycystic Kidney Disease
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