Funded in part by Danone, Danone Nutricia Research
Randomised controlled trial to determine the efficacy and safety of prescribed water intake to prevent kidney failure due to autosomal dominant polycystic kidney disease (PREVENT-ADPKD)
Wong ATY, Mannix C, Grantham JJ, Allman-Farinelli M, Badve SV, Boudville N, Byth K, Chan J, Coulshed S, Edwards ME, Erickson BJ, Fernando M, Foster S, Haloob I, Harris DCH, Hawley CM, Hill J, Howard K, Howell M, Jiang SH, Johnson DW, Kline TL, Kumar K, Lee VW, Lee VW, Lonergan M, Mai J, McCloud P, Peduto A, Rangan A, Roger SD, Sud K, Torres V, Vilayur E, Rangan GK
BMJ open · 55 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Danone
- University or hospital
- London Health Sciences Centre
- University or hospital
- Western Sydney Local Health District
- Company
- Danone Nutricia Research
- Government
- National Health and Medical Research Council
- University or hospital
- Sydney Medical School
- Government
- National Institute of Diabetes and Digestive and Kidney Diseases
- Government
- NIDDK NIH HHS
- Nonprofit
- Westmead Medical Research Foundation
- University or hospital
- Westmead Institute for Medical Research
- Authors
- At least one author declares a financial tie to industry
- Grants
- National Institute of Diabetes and Digestive and Kidney Diseases (P30-DK090728)
Based on 10 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2018-01-01 · BMJ Open · vol. 8 · issue 1 · p. e018794
- Publisher
- BMJ
- Cited
- 87 citations · more than 98% of similar papers · 8.3× the field average
- Impact
- Top 10% most cited in its field
- References
- 52 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Genetic and Kidney Cyst Diseases · Dialysis and Renal Disease Management · Electrolyte and hormonal disorders
- Keywords
- Medicine, Autosomal dominant polycystic kidney disease, Renal function, Kidney disease, Urine osmolality, Tolvaptan, Internal medicine, Polycystic kidney disease, Urine specific gravity, Clinical endpoint, Randomized controlled trial, Vasopressin, Kidney, Urology, Urine
- MeSH
- kidney, humans, polycystic kidney, autosomal dominant, kidney failure, chronic, disease progression, magnetic resonance imaging, glomerular filtration rate, fluid therapy, prospective studies, blood pressure, drinking, osmolar concentration, text messaging
34 authors
From AU, US
- Annette T. Y. WongThe University of Sydney; Westmead Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
- Carly MannixThe University of Sydney; Westmead Hospital; Sydney Local Health District; Westmead Institute for Medical Research; Western Sydney Local Health District
- Jared J. GranthamUniversity Medical Center; University of Kansas Medical Center
- Margaret A Allman-FarinelliThe University of Sydney
- Sunil V. BadveSt George Hospital
- Neil C BoudvilleThe University of Western Australia; Harry Perkins Institute of Medical Research; Sir Charles Gairdner Hospital
Abstract
Introduction
Maintaining fluid intake sufficient to reduce arginine vasopressin (AVP) secretion has been hypothesised to slow kidney cyst growth in autosomal dominant polycystic kidney disease (ADPKD). However, evidence to support this as a clinical practice recommendation is of poor quality. The aim of the present study is to determine the long-term efficacy and safety of prescribed water intake to prevent the progression of height-adjusted total kidney volume (ht-TKV) in patients with chronic kidney disease (stages 1-3) due to ADPKD.
Methods and analysis
A multicentre, prospective, parallel-group, open-label, randomised controlled trial will be conducted. Patients with ADPKD (n=180; age ≤65 years, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2) will be randomised (1:1) to either the control (standard treatment+usual fluid intake) or intervention (standard treatment+prescribed fluid intake) group. Participants in the intervention arm will be prescribed an individualised daily fluid intake to reduce urine osmolality to ≤270 mOsmol/kg, and supported with structured clinic and telephonic dietetic review, self-monitoring of urine-specific gravity, short message service text reminders and internet-based tools. All participants will have 6-monthly follow-up visits, and ht-TKV will be measured by MRI at 0, 18 and 36 months. The primary end point is the annual rate of change in ht-TKV as determined by serial renal MRI in control vs intervention groups, from baseline to 3 years. The secondary end points are differences between the two groups in systemic AVP activity, renal disease (eGFR, blood pressure, renal pain), patient adherence, acceptability and safety.
Ethics and dissemination
The trial was approved by the Human Research Ethics Committee, Western Sydney Local Health District. The results will inform clinicians, patients and policy-makers regarding the long-term safety, efficacy and feasibility of prescribed fluid intake as an approach to reduce kidney cyst growth in patients with ADPKD.
Trial registration number
ANZCTR12614001216606.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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