Clinical trial NCT03102632: A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Official title: A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autosomal Dominant Polycystic Kidney
Lead sponsor: The Rogosin Institute
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2017-04-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Participants will have a period of usual fluid intake and a period of increased water intake over the course of the study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in total kidney volume, as measured from magnetic resonance imaging
timeFrame: 18 months
Secondary outcomes:
measure: Kidney function change
timeFrame: 18 months
measure: Change in urine and blood markers of response to high water intake
timeFrame: 18 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: The Rogosin Institute
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Martin Prince, MD
role: PRINCIPAL_INVESTIGATOR
References: