High Water Intake to Slow Progression of Polycystic Kidney Disease

Study Overview
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Brief Summary
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Polycystic kidney disease (PKD) is a genetic disease that occurs in 1 in 500 individuals and leads to kidney failure in half of all affected. Currently, no treatments exist for PKD. PKD-affected kidney cells divide and multiply inappropriately, and form fluid-filled sacs called cysts. Kidney cysts continue to grow throughout life, destroying normal kidney tissue, leading to kidney failure. Based on evidence from basic science research it is believed that drinking high amounts of water can slow the abnormal cysts growth. This study aims to look at changes in urine composition with high water intake in PKD-affected persons compared to healthy individuals.

Official Title
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The Effect of Water Loading on Urinary Biomarkers

Conditions
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Kidney, Polycystic, Autosomal Dominant

Intervention / Treatment
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* Other: Water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Autosomal Dominant Polycystic Kidney Disease by history, ultrasound, CT or MRI Healthy subjects without a diagnosis of Polycystic Kidney Disease by history, ultrasound, CT or MRI Ages between 18 and 65 Healthy subjects (without Polycystic Kidney Disease) must have an estimated glomerular filtration rate (eGFR by the MDRD equation) > 60 ml/min/1.73 m2 with no history of kidney disease Exclusion Criteria: Women who are pregnant or nursing Active dependency on drugs or alcohol Diagnosis of syndrome of inappropriate antidiuresis Currently taking a vasopressin agonist or antagonist Blood sodium level less than < 135 mEq/L For healthy participants, estimated glomerular filtration rate (level of kidney function) less than < 60 ml/min/1.73 m2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Polycystic Kidney Disease Patients<br>Patients who present with polycystic kidney disease (PKD) | Other: Water<br>* Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.<br>|
| Other: Healthy Patients<br> | Other: Water<br>* Participants will be first asked to drink 6 8-oz glasses of water over 2.5 hours on the first day, and then about 12 8-oz glasses of water over the course of the day for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Urine cAMP Concentration and Urine Osmolality (UOsm) | Urine cAMP (UcAMP) concentration and urine osmolality UOsm) were measured pre- and post-water loading: with 2.5L over 2 hours | pre- and post-water loading (2 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, Water Loading, Biomarkers