Clinical Trials Directory

Trials / Completed

CompletedNCT00759369

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
11 (actual)
Sponsor
University of Kansas · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

Autosomal dominant polycystic kidney disease (ADPKD) is the most common single gene disorder that is potentially fatal. ADPKD is caused by mutations in either of two genes (PKD1, PKD2). Cysts begin to develop primarily in renal collecting tubules in utero and continue to form and expand throughout the patient's life. One of the goals of the study is to formulate a water prescription for use in clinical trials to determine the effect of sustained water diuresis on the progression of ADPKD.

Detailed description

The proposed study will devise a quantitative model to estimate the amount of water an individual would need to ingest in order to lower the 24 h mean urine osmolality to a level below plasma (\~285 mOsm/Kg). This osmolality goal is chosen because the 24h median urine osmolality of humans is ordinarily \~753 mOsm/Kg, much greater than 285 mosm/Kg (6, 7). In other words, normal humans are usually anti-diuretic during waking hours and while asleep. Median 24h urine volume is \~1225 ml (range 1051 - 2270). In temperate climates the insensible losses of water in sweat, respiration and stool are nearly balanced by the water ingested in solid and semi-solid foods and derived from metabolism. Thus, daily urine volume measured upon arising in the morning is a reasonably good indicator of the volume of fluids drunk over the preceding 24 h.

Conditions

Interventions

TypeNameDescription
OTHERWater prescriptionWater prescription in 12 to 16 equally divided doses

Timeline

Start date
2008-09-01
Primary completion
2009-07-01
Completion
2009-07-01
First posted
2008-09-25
Last updated
2012-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00759369. Inclusion in this directory is not an endorsement.