N/A
N=23
High Water Intake to Slow Progression of Polycystic Kidney Disease
Kidney, Polycystic, Autosomal Dominant
Bottom Line
View on ClinicalTrials.gov: NCT00784030 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Change in Urine cAMP Concentration and Urine Osmolality (UOsm) — -2.6; -2.0 fold change in cAMP/UOsm (umol/UOsm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Water (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Urine cAMP Concentration and Urine Osmolality (UOsm) |
-2.6; -2.0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00784030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.