A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Primary Purpose
Autosomal Dominant Polycystic Kidney
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Water Intake
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney
Eligibility Criteria
Inclusion Criteria:
- pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
- estimated glomerular filtration rate of 40 ml/min or greater
- urine osmolality > 400 mOsm/L
Exclusion Criteria:
- estimated glomerular filtration rate less than 40 ml/min
- low blood sodium levels
- syndrome of inappropriate diuretic hormone
- use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)
- use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or dDAVP
- contraindications to magnetic resonance imaging (MRI) (pacemakers, defibrillators, implanted electronic devices, metallic foreign body)
Sites / Locations
- The Rogosin Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Water Intake
High Water Intake
Arm Description
For the first 6 months of the study, the participants will continue their usual water intake.
After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.
Outcomes
Primary Outcome Measures
Change in total kidney volume, as measured from magnetic resonance imaging
Total kidney volumes will be measured before and after the period of high water intake. Kidney volume growth with high water intake will be compared to baseline kidney volume growth.
Secondary Outcome Measures
Kidney function change
Blood creatinine levels will be measured and compared before and after the high water intake period.
Change in urine and blood markers of response to high water intake
Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.
Full Information
NCT ID
NCT03102632
First Posted
March 27, 2017
Last Updated
October 17, 2023
Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT03102632
Brief Title
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Official Title
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Rogosin Institute
Collaborators
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and effective long-term treatment regimen. Unfortunately, there are still no disease-specific treatment for ADPKD approved in the US. A rational step towards identifying such agents is to test therapies that have a proven safety profile with mechanisms of action that can counter the disease progression.
The purpose of this study is to investigate whether drinking increased amounts of water (water loading) might slow down polycystic kidney growth or kidney function decline. Water loading can cause the suppression of a pathway that causes fluid buildup and cyst growth. High water intake has been safely used in the clinical setting, such as in the case of kidney stone therapy. New York State tap water is widely available and safe, making it highly cost-effective as well.
Detailed Description
The study will involve 11 visits to the study site over 19 months. Participants will need to follow specific dietary and fluid recommendations. There will be physical examinations and medical history assessments at each visit. Testing will include undergoing magnetic resonance imaging (MRI), blood and urine tests. Study participants will be compensated for their time. Detailed study procedures will be reviewed upon contact with the study team.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.
Masking
Outcomes Assessor
Masking Description
The radiologist measuring kidney volumes will be masked to the study condition.
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Water Intake
Arm Type
No Intervention
Arm Description
For the first 6 months of the study, the participants will continue their usual water intake.
Arm Title
High Water Intake
Arm Type
Experimental
Arm Description
After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.
Intervention Type
Other
Intervention Name(s)
High Water Intake
Intervention Description
After 6 months of usual, unchanged diet and fluid intake, participants will be asked to increase the daily fluid intake based on the principal investigator's prescription. The actual amount of extra water prescribed will depend on the results of the participant's 24 hour urine test.
Primary Outcome Measure Information:
Title
Change in total kidney volume, as measured from magnetic resonance imaging
Description
Total kidney volumes will be measured before and after the period of high water intake. Kidney volume growth with high water intake will be compared to baseline kidney volume growth.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Kidney function change
Description
Blood creatinine levels will be measured and compared before and after the high water intake period.
Time Frame
18 months
Title
Change in urine and blood markers of response to high water intake
Description
Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.
Time Frame
18 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
estimated glomerular filtration rate of 40 ml/min or greater
urine osmolality > 400 mOsm/L
Exclusion Criteria:
estimated glomerular filtration rate less than 40 ml/min
low blood sodium levels
syndrome of inappropriate diuretic hormone
use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)
use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or dDAVP
contraindications to magnetic resonance imaging (MRI) (pacemakers, defibrillators, implanted electronic devices, metallic foreign body)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Prince, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rogosin Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
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