Autosomal Dominant Polycystic Kidney Disease Clinical Trial
Official title:
Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.
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.
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