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NCT Number: NCT03102632

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

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rogosin Institute

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in total kidney volume, as measured from magnetic resonance imaging

    Time frame: 18 months

    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.

Secondary outcomes

  1. Kidney function change

    Time frame: 18 months

    Blood creatinine levels will be measured and compared before and after the high water intake period.

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

    Time frame: 18 months.

    Blood and urine biomarkers of response to high water intake will be measured before and after the period of high water intake.

Sponsors and collaborators

Lead sponsor

The Rogosin Institute

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2017
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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