High Water Intake to Slow Progression of Polycystic Kidney Disease
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by New York University School of Medicine.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
New York University School of Medicine
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00784030
First received: October 31, 2008
Last updated: July 10, 2009
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Kidney, Polycystic, Autosomal Dominant |
Other: Water |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | The Effect of Water Loading on Urinary Biomarkers |
Resource links provided by NLM:
Genetics Home Reference related topics:
polycystic kidney disease
MedlinePlus related topics:
Drinking Water
U.S. FDA Resources
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- Change in urinary biomarkers [ Time Frame: One week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784030
Locations
| United States, New York | |
| New York University Langone Medical Center | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
New York University School of Medicine
Investigators
| Principal Investigator: | Irina Barash, M.D. | New York University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Irina Barash/ M.D., New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00784030 History of Changes |
| Other Study ID Numbers: | 08-774 |
| Study First Received: | October 31, 2008 |
| Last Updated: | July 10, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
Autosomal Dominant Polycystic Kidney Disease Polycystic Kidney Disease Water Loading Biomarkers |
Additional relevant MeSH terms:
|
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Kidney Diseases, Cystic |
ClinicalTrials.gov processed this record on May 23, 2013