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Abstract: PO1051

Risk of Hypokalemia in Hyperkalemic Hemodialysis Patients

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Fishbane, Steven, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States
  • Ford, Martin L., King's College Hospital Trust, London, United Kingdom
  • Fukagawa, Masafumi, Tokai University School of Medicine, Isehara, Japan
  • Mccafferty, Kieran, Barts Health NHS Trust, London, United Kingdom
  • Rastogi, Anjay, David Geffen School of Medicine, Los Angeles, California, United States
  • Spinowitz, Bruce S., NewYork-Presbyterian Queens, Queens, New York, United States
  • Staroselskiy, Konstantin, B. Braun Avitum Russland Clinics, St Petersburg, Russian Federation
  • Vishnevskiy, Konstantin, First Pavlov State Medical University of St Petersburg, St Petersburg, Russian Federation
  • Lisovskaja, Vera, AstraZeneca BioPharmaceuticals Research and Development, Gothenburg, Sweden
  • Al-shurbaji, Ayman, AstraZeneca BioPharmaceuticals Research and Development, Gothenburg, Sweden
  • Guzman, Nicolas Jose, AstraZeneca BioPharmaceuticals Research and Development, Gaithersburg, Maryland, United States
  • Bhandari, Sunil, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom
Background

Combined pre- and post-dialysis hypokalemia is associated with increased mortality risk. The Phase 3b DIALIZE study (NCT03303521) showed that sodium zirconium cyclosilicate (SZC) reduces pre-dialysis serum potassium (sK+) and is well tolerated in hemodialysis patients (pts) with hyperkalemia. In this post-hoc safety analysis of DIALIZE, we report hypokalemia events in the SZC and placebo (PBO) arms.

Methods

In DIALIZE, 196 pts were randomized blindly 1:1 to receive PBO (n=99) or SZC (n=97) 5 g starting dose once daily on non-dialysis days (4 days/week [wk]) for 8 wks, comprising a 4-wk SZC or PBO dose-titration phase (max 15 g) to achieve target pre-dialysis sK+ 4.0–5.0 mmol/L, and a 4-wk stable-dose evaluation phase. In this post-hoc analysis, the proportions of pts with hypokalemia (sK+ <3.5 mmol/L) pre-dialysis, post-dialysis, and combined pre- and post-dialysis at the same visit were tabulated by visit. Pts’ current pre-dialysis sK+ stratified by post-dialysis sK+ (≥3.5 vs <3.5 mmol/L) at the previous visit was also assessed.

Results

The frequency of pre-dialysis hypokalemia was comparable between SZC and PBO, with 5 pts in each arm accounting for 7 and 5 events, respectively. The proportion of pts with post-dialysis hypokalemia at each visit was greater with SZC than PBO. For all but 2 SZC pts with post-dialysis hypokalemia, pre-dialysis sK+ returned to ≥3.5 mmol/L at the next visit (Figure). In each arm, 1 pt had combined pre- and post-dialysis hypokalemia.

Conclusion

Despite the efficacy of SZC in lowering pre-dialysis sK+, SZC was not associated with a clinically significant increase in the frequency of pre-dialysis hypokalemia. Treatment with SZC vs PBO did not increase the frequency of combined pre- and post-dialysis hypokalemia which is associated with increased mortality risk.

Funding

  • Commercial Support