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High Water Intake in Polycystic Kidney Disease (DRINK)

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ClinicalTrials.gov Identifier: NCT02933268
Recruitment Status : Completed
First Posted : October 14, 2016
Last Update Posted : January 15, 2019
Sponsor:
Collaborators:
PKD Charity
Addenbrookes Charitable Trust
British Renal Society & British Kidney Patient Association
Information provided by (Responsible Party):
Dr Thomas Hiemstra, University of Cambridge

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

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Dietary Supplement: High water intake Other: Ad libitum water intake Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial
Actual Study Start Date : September 26, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ad libitum water intake
Ad libitum water intake, defined as intake guided by thirst to achieve a target urine osmolality > 300 mOsmo/kg
 Other: Ad libitum water intake
Water intake guided by thirst
Active Comparator: High water intake
Personalised daily water intake prescription to achieve target urine osmolality < 270 mOsm/kg.
 Dietary Supplement: High water intake
High water intake aimed at achieving an urine osmolality < 270mOsmo/kg. Individualised prescription for each participant based on the free water clearance formula calculation.


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients achieving a urine osmolality < 270 mOsm/kg [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Urine osmolality [ Time Frame: 8 weeks ]
    Achieved urine osmolality as a surrogate for vasopressin suppression

  2. Proportion of participants that can self-monitor and report urine specific gravity reliably [ Time Frame: 8 weeks ]
  3. Proportion of patients experiencing a serious adverse event [ Time Frame: 12 weeks ]
  4. Acute change in estimated GFR [ Time Frame: 4 weeks ]
    Evaluation of the change form baseline eGFR after 2 weeks

  5. Health-Related Quality of Life (HRQoL) [ Time Frame: 12 weeks ]
    Change from baseline HRQoL as estimated by EQ5D-5L

  6. Recruitment rate [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933268


Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
PKD Charity
Addenbrookes Charitable Trust
British Renal Society & British Kidney Patient Association
Investigators
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Principal Investigator: Thomas F Himestra Cambridge University Hospital NHS Foundation Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr Thomas Hiemstra, Honorary Consultant Nephrologist & Senior Trials Research Fellow, University of Cambridge
ClinicalTrials.gov Identifier: NCT02933268    
Other Study ID Numbers: 203565
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Dr Thomas Hiemstra, University of Cambridge:
Autosomal Dominant Polycystic Kidney Disease
Polycystic Kidney Disease
ADPKD
 Water
Vasopressin
Dietary
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Congenital Abnormalities
 Kidney Diseases, Cystic
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn