High Water Intake in Polycystic Kidney Disease (DRINK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02933268|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autosomal Dominant Polycystic Kidney Disease||Dietary Supplement: High water intake Other: Ad libitum water intake||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determining Feasibility of Randomisation to High vs ad Libitum Water Intake in Polycystic Kidney Disease: The DRINK Randomised Feasibility Trial|
|Actual Study Start Date :||September 26, 2016|
|Estimated Primary Completion Date :||March 31, 2018|
|Estimated Study Completion Date :||July 31, 2018|
Active Comparator: Ad libitum water intake
Ad libitum water intake, defined as intake guided by thirst to achieve a target urine osmolality > 300 mOsmo/kg
Other: Ad libitum water intake
Water intake guided by thirst
Active Comparator: High water intake
Personalised daily water intake prescription to achieve target urine osmolality < 270 mOsm/kg.
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.
- The proportion of patients achieving a urine osmolality < 270 mOsm/kg [ Time Frame: 8 weeks ]
- Urine osmolality [ Time Frame: 8 weeks ]Achieved urine osmolality as a surrogate for vasopressin suppression
- 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 ]Evaluation of the change form baseline eGFR after 2 weeks
- Health-Related Quality of Life (HRQoL) [ Time Frame: 12 weeks ]Change from baseline HRQoL as estimated by EQ5D-5L
- Recruitment rate [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933268
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, United Kingdom, CB2 0QQ|
|Principal Investigator:||Thomas F Himestra||Cambridge University Hospital NHS Foundation Trust|