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

NCT ID: NCT00759369

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-07-31

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Water prescription

Group Type: EXPERIMENTAL

Water prescription

Intervention Type: OTHER

Water prescription in 12 to 16 equally divided doses

Interventions

Water prescription

Water prescription in 12 to 16 equally divided doses

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Connie Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20876670 (View on PubMed)

Other Identifiers

11451

Identifier Type: -

Identifier Source: org_study_id