The DRINK Randomised Feasibility Trial V1.0
Research type
Research Study
Full title
Determining feasibility of Randomisation to high vs. ad libitum water Intake in Polycystic Kidney Disease: The DRINK randomised feasibility trial
IRAS ID
203565
Contact name
Thomas Hiemstra
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Clinicaltrials.gov Identifier
609/M/C/1631, Study Insurance Reference Number
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
In Autosomal Dominant Polycystic Kidney Disease (ADPKD) many fluid filled sacs called cysts form in both kidneys. These grow in size and number and over time replace much of the normal kidney tissue. This causes high blood pressure and chronic kidney disease. Kidney failure occurs in more than 50% by the age of 55 years. ADPKD is caused by a faulty gene that is passed on from a parent to their child. An affected parent has a 50% chance of passing on the gene to each of their children.
Vasopressin is a hormone that is usually involved in the body’s normal water balance. In states of dehydration the brain makes more vasopressin, which travels to the kidneys causing them to conserve water and produce concentrated urine. If the body is well hydrated, no vasopressin is released and dilute urine is produced. In ADPKD Vasopressin behaves abnormally and drives the cysts to grow. Therefore if we could stop vasopressin production through high water intake, could this slow the progression of ADPKD.
DRINK is a feasibility study done on a smaller scale, over a short period of time, to decide whether a large-scale definitive study will be possible. The primary purpose of DRINK is to determine whether giving participants a daily prescription for water intake, aimed at achieving dilute urine at a threshold that will stop vasopressin production by the body, is safe, sustainable and well tolerated by participants. We also want to show that a significant difference in urine concentration between our high and standard water intake groups is achievable. We will include people with ADPKD, mainly recruited from the Renal Genetics clinic in Addenbrooke’s hospital, although we will be advertising nationally for participants. The trial will take approximately 12 weeks, and will be carried out in Addenbrookes Hospital, Cambridge.REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0236
Date of REC Opinion
1 Jul 2016
REC opinion
Further Information Favourable Opinion