Autosomal Dominant Polycystic Kidney DiseaseDRINKNCT02933268
High Water Intake in Polycystic Kidney Disease
A study testing High water intake and Ad libitum water intake in people with Autosomal Dominant Polycystic Kidney Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Autosomal Dominant Polycystic Kidney Disease
- What is being tested?
- High water intake and Ad libitum water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Sep 2016to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
About this study
Official title: Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.
Read the detailed 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.
- Being tested
- High water intake, Ad libitum water intake
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, ADPKD, Water, Vasopressin, Dietary
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Polycystic Kidney Diseases, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ad libitum water intakeOther
Water intake guided by thirst
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Ad libitum water intake |
| High water intake | Active comparator | Personalised daily water intake prescription to achieve target urine osmolality < 270 mOsm/kg. Receives: Dietary Supplement: High water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients achieving a urine osmolality < 270 mOsm/kg
Measured: 8 weeks
Secondary outcomes (6)
Urine osmolality
Achieved urine osmolality as a surrogate for vasopressin suppression
Measured: 8 weeks
Proportion of participants that can self-monitor and report urine specific gravity reliably
Measured: 8 weeks
Proportion of patients experiencing a serious adverse event
Measured: 12 weeks
Acute change in estimated GFR
Evaluation of the change form baseline eGFR after 2 weeks
Measured: 4 weeks
Health-Related Quality of Life (HRQoL)
Change from baseline HRQoL as estimated by EQ5D-5L
Measured: 12 weeks
Recruitment rate
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start26 Sep 2016
- Primary completion31 Mar 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- PKD Charity, Addenbrookes Charitable Trust, British Renal Society & British Kidney Patient Association
- Responsible party
- Principal investigator, Dr Thomas Hiemstra, University of Cambridge
- Investigators
- Thomas F Himestra, Principal investigator, Cambridge University Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933268
- Sponsor's protocol ID
- 203565
- Acronym
- DRINK
- Status last verified
- Jan 2019
- First submitted
- 18 Sep 2016
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39356039El-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.
PubMed 29743334
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial
- ClinicalTrials.gov ID
- NCT02933268
- Acronym / sponsor ID
- DRINK / 203565
- Keywords
- Autosomal Dominant Polycystic Kidney Disease, Polycystic Kidney Disease, ADPKD, Water, Vasopressin, Dietary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- PKD Charity, Addenbrookes Charitable Trust, British Renal Society & British Kidney Patient Association
- Study start
- 26 Sep 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DRINK is an open-label randomised controlled feasibility trial of high versus ad libitum water intake in ADPKD.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad libitum water intake | Active comparator | Other: Ad libitum water intakeAd libitum water intake, defined as intake guided by thirst to achieve a target urine osmolality > 300 mOsmo/kg |
| High water intake | Active comparator | Dietary Supplement: High water intakePersonalised daily water intake prescription to achieve target urine osmolality < 270 mOsm/kg. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High water intakeHigh water intake aimed at achieving an urine osmolality < 270mOsmo/kg. Individualised prescription for each participant based on the free water clearance formula calculation. | Dietary supplement | High water intake |
| Ad libitum water intakeWater intake guided by thirst | Other | Ad libitum water intake |
Primary outcome
The proportion of patients achieving a urine osmolality < 270 mOsm/kg
Time frame: 8 weeks
6 secondary outcomes
Urine osmolality
Time frame: 8 weeks
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
Acute change in estimated GFR
Time frame: 4 weeks
Health-Related Quality of Life (HRQoL)
Time frame: 12 weeks
Recruitment rate
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Derived from this study: PubMed 39356039St 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.
- Derived from this study: PubMed 29743334El-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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas F Himestra principal investigator
Cambridge University Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High water intake and Ad libitum water intake in people with Autosomal Dominant Polycystic Kidney Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients achieving a urine osmolality < 270 mOsm/kg (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.