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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00759369
First received: September 24, 2008
Last updated: February 24, 2012
Last verified: February 2012

September 24, 2008
February 24, 2012
September 2008
July 2009   (final data collection date for primary outcome measure)
Percentage of mean urine osmolality decreased from baseline [ Time Frame: Day 3, 4, 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00759369 on ClinicalTrials.gov Archive Site
  • Number of individuals who have an average daily solute excretion within 16.5% of baseline [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Number of individuals whose average total urine volume is within 18% of baseline. [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autosomal Dominant Polycystic Kidney Disease
Other: Water prescription
Water prescription in 12 to 16 equally divided doses
Experimental: 1
Water prescription
Intervention: Other: Water prescription
Wang CJ, Creed C, Winklhofer FT, Grantham JJ. Water prescription in autosomal dominant polycystic kidney disease: a pilot study. Clin J Am Soc Nephrol. 2011 Jan;6(1):192-7. Epub 2010 Sep 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ADPKD verified by ultrasound, CT or MRI, family history or physical exam
  • Normal creatinine clearance, calculated by Cockroft-Gault formulat
  • Good general health
  • Controlled blood pressure, < 140/90
  • Absence of urinary tract symptoms such as dysuria, hesitancy, diminished flow

Exclusion Criteria:

  • Azotemia
  • Uncontrolled hypertension
  • Urinary tract symptoms, dysuria, hesitancy, diminished flow, gross hematuria
  • Diabetes mellitus, cancer, hematologic disorder
  • Unable to follow directions
  • Solitary kidney
  • History of CHF, liver dysfunction or hyponatremia
  • Currently taking diuretics
  • Nephrotic range proteinuria (3.5 g/day)
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759369
11451
No
University of Kansas
University of Kansas
Not Provided
Principal Investigator: Connie Wang, MD University of Kansas
University of Kansas
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP