High Water Intake in Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

— DRINK  

Official title:

Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933268
• Other study ID #: 203565
• Status: Completed
• Phase: N/A
• Start date: September 26, 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: January 2019
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Dietary Supplement:
• High water intake
High water intake aimed at achieving an urine osmolality < 270mOsmo/kg. Individualised prescription for each participant based on the free water clearance formula calculation.

Other:
• Ad libitum water intake
Water intake guided by thirst

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge

Sponsors (4)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Addenbrookes Charitable Trust, British Renal Society & British Kidney Patient Association, PKD Charity

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients achieving a urine osmolality < 270 mOsm/kg		8 weeks
Secondary	Urine osmolality	Achieved urine osmolality as a surrogate for vasopressin suppression	8 weeks
Secondary	Proportion of participants that can self-monitor and report urine specific gravity reliably		8 weeks
Secondary	Proportion of patients experiencing a serious adverse event		12 weeks
Secondary	Acute change in estimated GFR	Evaluation of the change form baseline eGFR after 2 weeks	4 weeks
Secondary	Health-Related Quality of Life (HRQoL)	Change from baseline HRQoL as estimated by EQ5D-5L	12 weeks
Secondary	Recruitment rate		8 weeks