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

Autosomal Dominant Polycystic Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102632
• Other study ID #: 1701017921
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2023
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthrogryposis
• Autosomal Dominant Polycystic Kidney
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
The Rogosin Institute	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total kidney volume, as measured from magnetic resonance imaging	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.	18 months
Secondary	Kidney function change	Blood creatinine levels will be measured and compared before and after the high water intake period.	18 months
Secondary	Change in urine and blood markers of response to high water intake	Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.	18 months.