A randomised feasibility trial of high water intake in polycystic kidney disease (DRINK)

Not Applicable

Completed

• Conditions: Specialty: Renal disorders, Primary sub-specialty: Renal disorders; UKCRC code/ Disease: Renal and Urogenital/ Other disorders of kidney and ureter; Genetic Diseases; Autosomal Dominant Polycystic Kidney Disease

• Registration Number: ISRCTN16794957
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29743334 (added 20/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-23
• Study Completion: 2018-04-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Have given written informed consent to participate
2. Aged 16 years or older
3. Have a diagnosis of ADPKD (fulfilling radiological diagnostic criteria ± genetic evidence)
4. eGFR = 20ml/min/1.73m2
5. Able to self-monitor urine SG

Exclusion Criteria

1. Inability to provide informed consent
2. eGFR < 20ml/min
3. Fluid overload states e.g. heart failure, cirrhosis, or requirement for fluid restriction
4. Confounding illness impacting on renal disease e.g. concomitant diabetes or glomerulonephritis
5. Treatment with diuretics for fluid overload (those on diuretics for hypertension may participate in the trial after a run-in period of 2 weeks)
6. Treatment with Tolvaptan in the last 4 weeks
7. Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving a urine osmolality < 270 mOsm/kg is measured using 24 hour urine collections at screening, weeks 2, 8 and 12.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Urine osmolality is measured using 24 hour urine collections at screening, weeks 2, 8 and 12<br> 2. Proportion of participants that can self-monitor and report urine specific gravity reliably is measured using home monitoring of urine dipstick testing twice weekly (Monday and thursday) from weeks 0-8<br> 3. Proportion of patients experiencing a serious adverse event is measured using participant reported symptoms, clinic visits, and blood tests at weeks 0, 2, 4, 8 and 12<br> 4. Estimated GFR is measured using blood test at screening, then weeks 0, 2, 4, 8 and 12<br> 5. Health-Related Quality of Life is measured using the EQ5D-5L questionnaire at week 0 then week 12<br> 6. Recruitment rate is measured using the number of participants recruited each month<br>