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Trial record 21 of 114 for:    Polycystic Kidney Disease

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

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ClinicalTrials.gov Identifier: NCT03102632
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
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
Autosomal Dominant Polycystic Kidney Other: High Water Intake

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 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 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03102632


Contacts
Contact: Ines G Chicos 212-746-3541 inc9012@nyp.org
Contact: Irina Barash, MD, MS 212-746-9077 irb9023@nyp.org

Locations
United States, New York
The Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Ines G Chicos    212-746-3541    inc9012@nyp.org   
Contact: Irina Barash, MD, MS    212-746-9077    irb9023@nyp.org   
Sponsors and Collaborators
The Rogosin Institute
Weill Medical College of Cornell University
Investigators
Principal Investigator: Irina Barash, MD, MS The Rogosin Institute

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT03102632     History of Changes
Other Study ID Numbers: 1701017921
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn