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Abstract: SA-OR061

Sodium Zirconium Cyclosilicate (SZC) Improves Potassium Balance in Hyperkalemic Hemodialysis Patients: Results from the Phase 3b, Randomized, Placebo-Controlled DIALIZE Study

Session Information

  • Hemodialysis Potpourri
    November 09, 2019 | Location: 144, Walter E. Washington Convention Center
    Abstract Time: 05:06 PM - 05:18 PM

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 NHS 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, Gothenburg, Sweden
  • Al-shurbaji, Ayman, AstraZeneca, Gothenburg, Sweden
  • Guzman, Nicolas Jose, AstraZeneca, Gaithersburg, Maryland, United States
  • Bhandari, Sunil, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom
Background

Patients (pts) with end-stage renal disease frequently have persistent predialysis hyperkalemia (HK) despite hemodialysis (HD). The phase 3b, randomized, double-blind, placebo (PBO)-controlled DIALIZE trial (NCT03303521) investigated the effect of SZC on predialysis serum potassium (sK+) after the long interdialytic interval in HD pts with HK. To further examine the effect of SZC, several post hoc analyses were conducted.

Methods

In DIALIZE, 196 pts of mean age 58.1 [SD 13.7] years were randomized 1:1 to receive PBO (n=99) or SZC (n=97) 5 g once daily starting dose on non-dialysis days for 8 weeks, comprising a 4-week SZC dose-titration phase (max 15 g) to achieve target predialysis sK+ 4.0–5.0 mmol/L, and 4-week stable-dose evaluation phase (SZC 0, 5, 10 or 15 g). Post hoc analyses included assessment of the number of visits at which pts had sK+ of 4–5 mmol/L and 3.5–5.5 mmol/L, and the maximum sK+ during the evaluation phase. Change in K+ gradient (difference between the predialysis sK+ and dialysate K+ [dK+]) from baseline to end of evaluation phase was also assessed by cross tabulation of categorized dK+ (dK+ 2–3, 3–4, 4–5 and ≥5 mmol/L).

Results

A high sK+ to dK+ gradient at the start of HD permits rapid lowering of sK+ but can also be associated with a greater risk of adverse events, such as cardiac arrhythmias and hospitalizations. SZC was associated with more pts achieving sK+ 4.0–5.0 mmol/L and being maintained at sK+ 3.5–5.5 mmol/L vs PBO for 1, 2, 3 and 4 visits. 56 pts had severe predialysis HK (sK+ ≥6 mmol/L) in the PBO group during the evaluation period, compared with only 14 in the SZC group. A shift in K+ gradient towards values below the reported higher risk threshold of 3 mmol/L was observed in the SZC group, with 30.6% of pts (n=11/36) moving from gradient 4–5 to 2–3 mmol/L and 55.6% (n=25/45) from 3–4 to 2–3 mmol/L.

Conclusion

These findings suggest that treatment with SZC improves management and reduces the frequency of severe HK in HD pts, which could potentially modify the risks associated with these factors.

Funding

  • Commercial Support