Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02933268
Study type Interventional
Source Cambridge University Hospitals NHS Foundation Trust
Contact
Status Completed
Phase N/A
Start date September 26, 2016
Completion date July 31, 2018

See also
  Status Clinical Trial Phase
Completed NCT00759369 - Water as Therapy in Autosomal Dominant Polycystic Kidney Disease (ADPKD) N/A
Completed NCT00598377 - Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease N/A
Completed NCT01039987 - Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease N/A
Completed NCT03717883 - ADPKD Alterations in Hepatic Transporter Function
Recruiting NCT05193981 - A Study to Evaluate Homocysteine Metabolism and Endothelial Function in ADPKD
Completed NCT03487913 - The ELiSA Study - Evaluation of Lixivaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease Phase 2
Not yet recruiting NCT06435858 - Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease Phase 4
Recruiting NCT05190744 - PB to Treat Hereditary Nephrogenic Diabetes Insipidus, ADPKD Treated With Tolvaptan, and Severely Polyuric Patients With Previous Lithium Administration Phase 2
Recruiting NCT05521191 - A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease Phase 1
Recruiting NCT04344769 - Characterization of the Nrf2 Response in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Active, not recruiting NCT02848521 - A Study Measuring Quality of Life, Treatment Preference and Satisfaction of ADPKD Patients in Europe
Completed NCT01451827 - 8-Week Study of Tolvaptan Dose Forms in Autosomal Dominant Polycystic Kidney Disease (ADPKD) Phase 2
Completed NCT01210560 - Dose-finding Study of New Tolvaptan Formulation in Subjects With ADPKD Phase 2
Completed NCT01336972 - Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD) Phase 2
Completed NCT02134899 - The Efficacy of Everolimus in Reducing Total Native Kidney Volume in Polycystic Kidney Disease Transplanted Recipients Phase 3
Active, not recruiting NCT02729662 - Efficacy of Tolvaptan on ADPKD Patients N/A
Recruiting NCT06065852 - National Registry of Rare Kidney Diseases
Recruiting NCT05288998 - Intrarenal Microvasculature in ADPKD
Recruiting NCT04939935 - Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD) Phase 3
Withdrawn NCT01988038 - Repository Study of Autosomal Dominant Polycystic Kidney Disease N/A