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 autosomal dominant polycystic kidney disease (ADPKD)
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.
In the best-case scenario, if prescribed fluid intake is found to reduce the annualised rate of increase in TKV by 50%, the development of ESKD could be delayed by 6.5 years and life expectancy extended by 2.6 years,51 at a negligible cost over standard treatment, but resulting in considerable cost savings for future treatments of ESKD.
Even at lower efficacy this treatment option will be extremely good value for money and this is of vital importance in low-income countries where access to novel drugs and chronic dialysis are restricted due to lack of affordability and availability. However, if the hypothesis is proven, the largest impact will be in children and at-risk individuals with ADPKD
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.