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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

Brief 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 Summary: 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.
Sponsor: University of Kansas

Current Primary Outcome: Percentage of mean urine osmolality decreased from baseline [ Time Frame: Day 3, 4, 5 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of individuals who have an average daily solute excretion within 16.5% of baseline [ Time Frame: End of study ]
  • Number of individuals whose average total urine volume is within 18% of baseline. [ Time Frame: End of study ]


Original Secondary Outcome: Same as current

Information By: University of Kansas Medical Center

Dates:
Date Received: September 24, 2008
Date Started: September 2008
Date Completion:
Last Updated: February 24, 2012
Last Verified: February 2012