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

The Rogosin Institute

Status: Completed

Conditions: Autosomal Dominant Polycystic Kidney

Treatments: Other: High Water Intake

Study type: Interventional

Funder types: Other

Identifiers

NCT03102632

1701017921

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Usual Water Intake

No Intervention group

Description:

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

High Water Intake

Experimental group

Description:

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

Treatment:

Other: High Water Intake