Clinical Trial: A Randomised Feasibility Trial of High Water Intake in Polycystic Kidney Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Summary:

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.


Sponsor: Cambridge University Hospitals NHS Foundation Trust

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: September 18, 2016
Date Started: September 2016
Date Completion: September 2017
Last Updated: October 12, 2016
Last Verified: October 2016