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

NCT03102632 | Completed

• 1 other identifier: 1701017921
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Autosomal Dominant Polycystic Kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Kidney function change

  18 months

• Change in urine and blood markers of response to high water intake

  18 months.

Study Arms (2)

Usual Water Intake

NO INTERVENTION

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

High Water Intake

EXPERIMENTAL

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

Other: High Water Intake

Interventions

High Water Intake 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.

High Water Intake

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
• estimated glomerular filtration rate of 40 ml/min or greater
• urine osmolality \> 400 mOsm/L

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Rogosin Institute: lead
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

Related Publications (1)

• Dev H, Zhu C, Barash I, Blumenfeld JD, He X, RoyChoudhury A, Wu A, Prince MR. Feasibility of Water Therapy for Slowing Autosomal Dominant Polycystic Kidney Disease Progression. Kidney360. 2024 May 1;5(5):698-706. doi: 10.34067/KID.0000000000000428. Epub 2024 Apr 1.

  PMID: 38556640 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Martin Prince, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologist measuring kidney volumes will be masked to the study condition.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 6, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)