High Water Intake in Polycystic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02933268
• Date of registration: 18/09/2016
• Prospective Registration: Yes
• Primary sponsor: Cambridge University Hospitals NHS Foundation Trust
• Public title: High Water Intake in Polycystic Kidney Disease DRINK
• Scientific title: Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial
• Date of first enrolment: September 26, 2016
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02933268
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Thomas F Himestra
• Affiliation: Cambridge University Hospital NHS Foundation Trust

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease

Intervention(s)

Other: Ad libitum water intake

Dietary Supplement: High water intake

Primary Outcome(s)

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

Secondary Outcome(s)

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]

Recruitment rate [Time Frame: 8 weeks]

Acute change in estimated GFR [Time Frame: 4 weeks]

Health-Related Quality of Life (HRQoL) [Time Frame: 12 weeks]

Urine osmolality [Time Frame: 8 weeks]

Secondary ID(s)

203565

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

British Renal Society & British Kidney Patient Association

Addenbrookes Charitable Trust

PKD Charity