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A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03102632
Recruitment Status : Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : September 28, 2021
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute

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.

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Other: High Water Intake Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: The radiologist measuring kidney volumes will be masked to the study condition.
Primary Purpose: Treatment
Official Title: A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
No Intervention: Usual Water Intake
For the first 6 months of the study, the participants will continue their usual water intake.
Experimental: High Water Intake
After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.
Other: High Water Intake
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 Measures :
  1. Change in total kidney volume, as measured from magnetic resonance imaging [ Time Frame: 18 months ]
    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 :
  1. Kidney function change [ Time Frame: 18 months ]
    Blood creatinine levels will be measured and compared before and after the high water intake period.

  2. Change in urine and blood markers of response to high water intake [ Time Frame: 18 months. ]
    Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03102632

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United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
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Principal Investigator: Irina Barash, MD, MS Weill Medical College of Cornell University
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Responsible Party: The Rogosin Institute Identifier: NCT03102632    
Other Study ID Numbers: 1701017921
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Genetic Diseases, Inborn