Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Water prescription
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring ADPKD
Eligibility Criteria
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)
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Water prescription
Outcomes
Primary Outcome Measures
Percentage of mean urine osmolality decreased from baseline
Secondary Outcome Measures
Number of individuals who have an average daily solute excretion within 16.5% of baseline
Number of individuals whose average total urine volume is within 18% of baseline.
Full Information
NCT ID
NCT00759369
First Posted
September 24, 2008
Last Updated
February 24, 2012
Sponsor
University of Kansas
1. Study Identification
Unique Protocol Identification Number
NCT00759369
Brief Title
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Official Title
Water as Therapy in Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease
Keywords
ADPKD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Water prescription
Intervention Type
Other
Intervention Name(s)
Water prescription
Intervention Description
Water prescription in 12 to 16 equally divided doses
Primary Outcome Measure Information:
Title
Percentage of mean urine osmolality decreased from baseline
Time Frame
Day 3, 4, 5
Secondary Outcome Measure Information:
Title
Number of individuals who have an average daily solute excretion within 16.5% of baseline
Time Frame
End of study
Title
Number of individuals whose average total urine volume is within 18% of baseline.
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Wang, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20876670
Citation
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. doi: 10.2215/CJN.03950510. Epub 2010 Sep 28.
Results Reference
derived
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Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
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