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High Water Intake in Polycystic Kidney Disease (DRINK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 18, 2016
First Posted Date  ICMJE October 14, 2016
Last Update Posted Date January 15, 2019
Actual Study Start Date  ICMJE September 26, 2016
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
The proportion of patients achieving a urine osmolality < 270 mOsm/kg [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
  • Urine osmolality [ Time Frame: 8 weeks ]
    Achieved urine osmolality as a surrogate for vasopressin suppression
  • Proportion of participants that can self-monitor and report urine specific gravity reliably [ Time Frame: 8 weeks ]
  • Proportion of patients experiencing a serious adverse event [ Time Frame: 12 weeks ]
  • Acute change in estimated GFR [ Time Frame: 4 weeks ]
    Evaluation of the change form baseline eGFR after 2 weeks
  • Health-Related Quality of Life (HRQoL) [ Time Frame: 12 weeks ]
    Change from baseline HRQoL as estimated by EQ5D-5L
  • Recruitment rate [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Water Intake in Polycystic Kidney Disease
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autosomal Dominant Polycystic Kidney Disease
Intervention  ICMJE
  • 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.
  • Other: Ad libitum water intake
    Water intake guided by thirst
Study Arms  ICMJE
  • 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
    Intervention: Other: Ad libitum water intake
  • Active Comparator: High water intake
    Personalised daily water intake prescription to achieve target urine osmolality < 270 mOsm/kg.
    Intervention: Dietary Supplement: High water intake
Publications * El-Damanawi R, Lee M, Harris T, Mader LB, Bond S, Pavey H, Sandford RN, Wilkinson IB, Burrows A, Woznowski P, Ben-Shlomo Y, Karet Frankl FE, Hiemstra TF. Randomised controlled trial of high versus ad libitum water intake in patients with autosomal dominant polycystic kidney disease: rationale and design of the DRINK feasibility trial. BMJ Open. 2018 May 9;8(5):e022859. doi: 10.1136/bmjopen-2018-022859.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2019)
42
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2016)
50
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02933268
Other Study ID Numbers  ICMJE 203565
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Dr Thomas Hiemstra, University of Cambridge
Study Sponsor  ICMJE Cambridge University Hospitals NHS Foundation Trust
Collaborators  ICMJE
  • PKD Charity
  • Addenbrookes Charitable Trust
  • British Renal Society & British Kidney Patient Association
Investigators  ICMJE
Principal Investigator: Thomas F Himestra Cambridge University Hospital NHS Foundation Trust
PRS Account Cambridge University Hospitals NHS Foundation Trust
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP