Disease
Autosomal Dominant Polycystic Kidney Disease

Protocol Title
A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Disease

Principal Investigator
Irina Barash, MD
Office Number: (212) 746-3541
Email: irb9023@nyp.org

Study Status
Open for Enrollment

Brief Summary of the Protocol
Patients affected by Autosomal Dominant Polycystic Kidney Disease (ADPKD) need a safe and effective long-term treatment regimen. Unfortunately, we still do not have any disease-specific treatment for ADPKD. 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.

Key eligibility
• A diagnosis of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Age 18 to 65 years
• Ability to undergo magnetic resonance imaging (MRI)
Additional eligibility criteria will be reviewed when you contact the study team.

Treatment Overview
• 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.
• Detailed study procedures will be reviewed when you contact the study team.

Study participants will receive a small stipend per visit for their time.

Potential Benefits
There is no guarantee that participants will receive direct benefit from this study. However, possible benefit may be gaining more knowledge about your kidney size from the MRI scans. We hope the information learned from this study will benefit other patients with polycystic kidney disease in the future.

Sponsor/Funding Information
New York State (NYS) Empire Clinical Research Investigator Program (ECRIP) Award

Institutional Review Board (IRB)
Weill Cornell Medicine IRB
Protocol #: 1701017921
ClinicalTrials.gov Identifier:  NCT03102632