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

Sponsor

University of Kansas (Other)

Overall Status

Completed

CT.gov ID

NCT00759369

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease	Other: Water prescription	N/A

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.

Study Design

Study Type:

Interventional

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 :

Sep 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Water prescription

Other: Water prescription

Water prescription in 12 to 16 equally divided doses

Outcome Measures

Primary Outcome Measures

Percentage of mean urine osmolality decreased from baseline [Day 3, 4, 5]

Secondary Outcome Measures

Number of individuals who have an average daily solute excretion within 16.5% of baseline [End of study]
Number of individuals whose average total urine volume is within 18% of baseline. [End of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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 Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Kansas

ClinicalTrials.gov Identifier:

NCT00759369

Other Study ID Numbers:

11451

First Posted:

Sep 25, 2008

Last Update Posted:

Feb 27, 2012

Last Verified:

Feb 1, 2012

Keywords provided by University of Kansas

ADPKD

Additional relevant MeSH terms:

Arthrogryposis

Kidney Diseases

Polycystic Kidney Diseases

Polycystic Kidney, Autosomal Dominant

Study Results

No Results Posted as of Feb 27, 2012