Kidney Week

Abstract: SA-PO483

A Randomised Feasibility Trial of High vs Ad Libitum Water Intake in Autosomal Polycystic Kidney Disease

Session Information

• ADPKD: Clinical Studies
  October 27, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Genetic Diseases of the Kidney

• 1001 Genetic Diseases of the Kidney: Cystic

Authors

• El- Damanawi, Ragada, Division of Experimental Medicine and Immunotherapeutics, Cambridge, United Kingdom

Ragada El- Damanawi,

• Lee, Michael C., University of Cambridge, Cambridge, United Kingdom

Michael C. Lee,

• Harris, Tess M., Polycystic Kidney Disease Charity, London, United Kingdom

Tess M. Harris,

• Mader, Laura B., Patient Led Research Hub, Cambridge, United Kingdom

Laura B. Mader,

• Pavey, Holly, Cambridge Clinical Trials Unit, Cambridge, United Kingdom

Holly Pavey,

• Wilkinson, Ian, Division of Experimental Medicine and Immunotherapeutics, Cambridge, United Kingdom

Ian Wilkinson,

• Burrows, Alison, University of Bristol, Bristol, United Kingdom

Alison Burrows,

• Woznowski, Przemyslaw R., University of Bristol, Bristol, United Kingdom

Przemyslaw R. Woznowski,

• Ben-shlomo, Yoav, University of Bristol, Bristol, United Kingdom

Yoav Ben-shlomo,

• Karet, Fiona E., University of Cambridge, Cambridge, United Kingdom

Fiona E. Karet,

• Hiemstra, Thomas F., Division of Experimental Medicine and Immunotherapeutics, Cambridge, United Kingdom

Thomas F. Hiemstra,

Background

High water intake is a rational therapeutic approach in Autosomal Dominant Polycystic Kidney Disease (ADPKD) and may have similar benefits to tolvaptan, but the efficacy of high water intake in slowing ADPKD progression has not been assessed. It is not known whether a randomised trial of high water intake in ADPKD would be feasible.

Methods

In a single-centre, open label randomised controlled feasibility trial, we assigned adult ADPKD patients with an eGFR≥20ml/min/1.73m2 to either 1) individualised daily fluid prescription with target urine osmolality ≤270mOsm/kg (HW), or 2) drinking to thirst (AW), over 8 weeks. Co-primary feasibility endpoints were the recruitment rate and separation between treatment arms in urine osmolality.

Results

42 participants (57% female, age 46±13 years) were randomised (1:1) to HW (n=21) and AW (n=21) at a recruitment rate of 1 patient every 10 days. Baseline characteristics did not differ between trial arms (eGFR 68.4 (35.9-107.2) vs 75.8 (35.9-107.2) ml/min respectively). Significantly more HW patients achieved the target uOsm (14/21, 67%) compared to the AW group (5/21, 24%) during the 8 week treatment period (p<0.001), with uOsm significantly lower throughout follow-up in the in the HW group (Figure, p=0.02). There were no significant differences in CKD-EPI eGFR between arms, and no acute effects on ⁵¹Cr-EDTA GFR.

Conclusion

Rapid recruitment to the trial, compliance with prescribed fluid intake, and separation between trial arms in uOsm suggest that a large-scale trial of high water intake in ADPKD is feasible.

Change in urine osmolality over time by treatment group