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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: The Rogosin Institute

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Kidney function change [ Time Frame: 18 months ]
    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 [ 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.


Original Secondary Outcome: Same as current

Information By: The Rogosin Institute

Dates:
Date Received: March 27, 2017
Date Started: May 2017
Date Completion: April 2019
Last Updated: May 1, 2017
Last Verified: May 2017