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

Not Applicable

Completed

• Conditions: Autosomal Dominant Polycystic Kidney
• Interventions: Other: High Water Intake

• Registration Number: NCT03102632
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-30
• Study First Posted: 2017-04-06
• Study Start: 2017-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
High Water Intake	High Water Intake	After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.

Primary Outcome Measures

Name	Time	Method
Change in total kidney volume, as measured from magnetic resonance imaging	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

Name	Time	Method
Kidney function change	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	18 months.	Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.

Trial Locations

Locations (1)

The Rogosin Institute; 🇺🇸 New York, New York, United States