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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autosomal Dominant Polycystic Kidney

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The radiologist measuring kidney volumes will be masked to the study condition.

Study Groups

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Usual Water Intake

For the first 6 months of the study, the participants will continue their usual water intake.

Group Type NO_INTERVENTION

No interventions assigned to this group

High Water Intake

After a 6 month period of usual water intake, a high water intake daily amount will be prescribed for 1 year.

Group Type EXPERIMENTAL

High Water Intake

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No