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

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

Official title:

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759369
• Other study ID #: 11451
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: February 24, 2012
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: February 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Other:
• Water prescription
Water prescription in 12 to 16 equally divided doses

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of mean urine osmolality decreased from baseline		Day 3, 4, 5	No
Secondary	Number of individuals who have an average daily solute excretion within 16.5% of baseline		End of study	No
Secondary	Number of individuals whose average total urine volume is within 18% of baseline.		End of study	No