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

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Brief Title

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

Official Title

Water as Therapy in Autosomal Dominant Polycystic Kidney Disease

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.
    


Study Type

Interventional


Primary Outcome

Percentage of mean urine osmolality decreased from baseline

Secondary Outcome

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

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Water prescription

Study Arms / Comparison Groups

 1
Description:  Water prescription

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

11

Start Date

September 2008

Completion Date

July 2009

Primary Completion Date

July 2009

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)
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Connie Wang, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00759369

Organization ID

11451


Responsible Party

Sponsor

Study Sponsor

University of Kansas


Study Sponsor

Connie Wang, MD, Principal Investigator, University of Kansas Medical Center


Verification Date

February 2012