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
  Purpose

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 Intervention
Autosomal Dominant Polycystic Kidney Disease
Other: Water prescription

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Percentage of mean urine osmolality decreased from baseline [ Time Frame: Day 3, 4, 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Water prescription
Other: Water prescription
Water prescription in 12 to 16 equally divided doses

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759369

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Connie Wang, MD University of Kansas
  More Information

No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00759369     History of Changes
Other Study ID Numbers: 11451
Study First Received: September 24, 2008
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
ADPKD

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on July 26, 2014