High Water Intake in Polycystic Kidney Disease

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Brief Title

High Water Intake in Polycystic Kidney Disease

Official Title

Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial

Brief Summary

      DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum
      water intake in ADPKD.
    

Detailed Description

      Autosomal Dominant Polycystic Kidney Disease (PKD) affects 12.5 million people worldwide, and
      accounts for 7% of those requiring renal replacement therapy. The hormone vasopressin drives
      cyst growth until ultimately most of the normal functioning kidney tissue is replaced and
      compressed by cysts over the life course. Half of those affected will require dialysis by the
      age of 55 years.

      Vasopressin blockade has emerged as a viable strategy for altering disease course. High water
      intake suppresses vasopressin, and may therefore slow cyst growth and consequent disease
      progression. However, evidence to support high water intake in PKD is lacking, and it is not
      clear whether patients can adhere sufficiently to a high water intake.

      DRINK is a single-centre prospective, open label, parallel group randomised controlled
      feasibility trial. The primary objective is to establish whether a definitive large
      randomised trial comparing high versus ad libitum water intake on long-term disease
      progression is deliverable. Fifty patients will be recruited from the Renal Genetics service
      at Addenbrooke's Hospital. Participants will be randomly allocated to the high water intake
      (high) or the ad libitum (standard) water intake group. For the high intake group the aim is
      to drink large enough volumes of water to achieve and maintain dilute urine (urine osmolality
      < 270 mOsmo/kg or urine specific gravity ≤ 1.010 ). Multiple methods will be employed to
      promote adherence these include instruction and education as well as self-monitoring of urine
      specific gravity twice weekly by participants and the recording of results via a trial
      specific smartphone application.
    


Study Type

Interventional


Primary Outcome

The proportion of patients achieving a urine osmolality < 270 mOsm/kg

Secondary Outcome

 Urine osmolality

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

High water intake

Study Arms / Comparison Groups

 Ad libitum water intake
Description:  Ad libitum water intake, defined as intake guided by thirst to achieve a target urine osmolality > 300 mOsmo/kg

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

Dietary Supplement

Estimated Enrollment

42

Start Date

September 26, 2016

Completion Date

July 31, 2018

Primary Completion Date

March 31, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Have given written informed consent to participate

          -  Aged 16 years or older

          -  Have a diagnosis of ADPKD (fulfilling radiological diagnostic criteria ± genetic
             evidence)

          -  eGFR ≥ 20ml/min/1.73m2

          -  Able to self-monitor urine SG

        Exclusion Criteria:

          -  Inability to provide informed consent

          -  eGFR < 20ml/min/1.73m2

          -  Fluid overload states e.g. heart failure, cirrhosis, or requirement for fluid
             restriction

          -  Confounding illness impacting on renal disease e.g. concomitant diabetes or
             glomerulonephritis

          -  Treatment with diuretics for fluid overload (those on diuretics for hypertension may
             participate in the trial after a run-in period of 2 weeks)

          -  Treatment with Tolvaptan in the last 4 weeks

          -  Pregnancy or breastfeeding
      

Gender

All

Ages

16 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas F Himestra, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02933268

Organization ID

203565


Responsible Party

Principal Investigator

Study Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

 PKD Charity

Study Sponsor

Thomas F Himestra, Principal Investigator, Cambridge University Hospital NHS Foundation Trust


Verification Date

January 2019