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Completed

NCT Number: NCT00759369

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

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Water prescription

Other

Water prescription in 12 to 16 equally divided doses

Primary outcomes

  1. Percentage of mean urine osmolality decreased from baseline

    Time frame: Day 3, 4, 5

Secondary outcomes

  1. Number of individuals who have an average daily solute excretion within 16.5% of baseline

    Time frame: End of study

  2. Number of individuals whose average total urine volume is within 18% of baseline.

    Time frame: End of study

Sponsors and collaborators

Lead sponsor

University of Kansas

Other

Registry information

Official study title

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 25, 2008
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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