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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00759369
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )

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.

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Other: Water prescription Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Water as Therapy in Autosomal Dominant Polycystic Kidney Disease
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Arm Intervention/treatment
Experimental: 1
Water prescription
Other: Water prescription
Water prescription in 12 to 16 equally divided doses

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00759369

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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
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Principal Investigator: Connie Wang, MD University of Kansas Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Kansas Identifier: NCT00759369    
Other Study ID Numbers: 11451
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012
Keywords provided by University of Kansas Medical Center ( University of Kansas ):
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Genetic Diseases, Inborn