We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 13 of 100 for:    "Polycystic Kidney Disease"

A Randomised Feasibility Trial of High Water Intake in Polycystic Kidney Disease (DRINK)

This study is not yet open for participant recruitment.
Verified October 2016 by Dr Thomas Hiemstra, University of Cambridge
Sponsor:
ClinicalTrials.gov Identifier:
NCT02933268
First Posted: October 14, 2016
Last Update Posted: October 14, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
PKD Charity
Addenbrookes Charitable Trust
British Renal Society & British Kidney Patient Association
Information provided by (Responsible Party):
Dr Thomas Hiemstra, University of Cambridge
  Purpose
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.

Condition Intervention
Autosomal Dominant Polycystic Kidney Disease Dietary Supplement: High water intake Other: Ad libitum water intake

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr Thomas Hiemstra, University of Cambridge:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: September 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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


Contacts
Contact: Thomas F Hiemstra +44(0)122336817 add-tr.drinktrial@nhs.net
Contact: Ragada El-Damanawi +44(0)1223596471 add-tr.drinktrial@nhs.net

Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Stephen Kelleher    01223217418    r&denquiries@addenbrookes.nhs.uk   
Principal Investigator: Thomas Dr Hiemstra         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
PKD Charity
Addenbrookes Charitable Trust
British Renal Society & British Kidney Patient Association
Investigators
Principal Investigator: Thomas F Himestra Cambridge University Hospital NHS Foundation Trust
  More Information

Responsible Party: Dr Thomas Hiemstra, Honorary Consultant Nephrologist & Senior Trials Research Fellow, University of Cambridge
ClinicalTrials.gov Identifier: NCT02933268     History of Changes
Other Study ID Numbers: 203565
First Submitted: September 18, 2016
First Posted: October 14, 2016
Last Update Posted: October 14, 2016
Last Verified: October 2016
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:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic


To Top