NCT02933268

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

September 26, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

September 18, 2016

Last Update Submit

January 13, 2019

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

Autosomal Dominant Polycystic Kidney DiseasePolycystic Kidney DiseaseADPKDWaterVasopressinDietary

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients achieving a urine osmolality < 270 mOsm/kg

    8 weeks

Secondary Outcomes (6)

  • Urine osmolality

    8 weeks

  • Proportion of participants that can self-monitor and report urine specific gravity reliably

    8 weeks

  • Proportion of patients experiencing a serious adverse event

    12 weeks

  • Acute change in estimated GFR

    4 weeks

  • Health-Related Quality of Life (HRQoL)

    12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Ad libitum water intake

ACTIVE COMPARATOR

Ad libitum water intake, defined as intake guided by thirst to achieve a target urine osmolality \> 300 mOsmo/kg

Other: Ad libitum water intake

High water intake

ACTIVE COMPARATOR

Personalised daily water intake prescription to achieve target urine osmolality \< 270 mOsm/kg.

Dietary Supplement: High water intake

Interventions

High water intakeDIETARY_SUPPLEMENT

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

High water intake
Ad libitum water intakeOTHER

Water intake guided by thirst

Ad libitum water intake

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (2)

  • St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

    PMID: 39356039DERIVED

  • El-Damanawi R, Lee M, Harris T, Mader LB, Bond S, Pavey H, Sandford RN, Wilkinson IB, Burrows A, Woznowski P, Ben-Shlomo Y, Karet Frankl FE, Hiemstra TF. Randomised controlled trial of high versus ad libitum water intake in patients with autosomal dominant polycystic kidney disease: rationale and design of the DRINK feasibility trial. BMJ Open. 2018 May 9;8(5):e022859. doi: 10.1136/bmjopen-2018-022859.

    PMID: 29743334DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantPolycystic Kidney DiseasesDiabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases, CysticKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, InbornPituitary DiseasesEndocrine System Diseases

Study Officials

  • Thomas F Himestra

    Cambridge University Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Consultant Nephrologist & Senior Trials Research Fellow

Study Record Dates

First Submitted

September 18, 2016

First Posted

October 14, 2016

Study Start

September 26, 2016

Primary Completion

March 31, 2018

Study Completion

July 31, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Locations

GB(1)