Potassium responses to sodium zirconium cyclosilicate in hyperkalemic hemodialysis patients: post-hoc analysis of DIALIZE.

Abstract

BACKGROUND:

Sodium zirconium cyclosilicate (SZC) is an effective and well-tolerated treatment for hyperkalemia in maintenance hemodialysis patients. In post-hoc analyses of the phase 3b DIALIZE study, we examined the spectrum of potassium responses to SZC.

METHODS:

Post-hoc analyses with SZC and placebo included: the number of long interdialytic interval (LIDI) visits during the 4-week evaluation period where patients attained pre-dialysis serum potassium (sK+) concentrations of 4.0-5.0 and 4.0-5.5 mmol/L; potassium gradient (the difference between pre-dialysis sK+ and dialysate potassium) at days 36, 43, 50, and 57, and change from baseline to the end of treatment (EOT) using categories of potassium gradient (1 to < 2, 2 to < 3, 3 to < 4, and ≥ 4 mmol/L).

RESULTS:

A greater proportion of patients achieved the ranges of pre-dialysis sK+ concentration with SZC versus placebo for ≥1, ≥ 2, ≥ 3, and 4 LIDI visits over 4 weeks; 23.7 and 48.5% of patients in the SZC group achieved pre-dialysis sK+ concentrations of 4.0-5.0 and 4.0-5.5 mmol/L, respectively, at all 4 LIDI visits. Baseline mean potassium gradient was similar with SZC and placebo. At day 57, mean (standard deviation) potassium gradient was 2.78 (0.08) mmol/L with SZC and 3.52 (0.08) mmol/L with placebo; mean difference (95% confidence interval) was - 0.74 mmol/L (- 0.97 to - 0.52). A greater reduction in potassium gradient category from baseline towards lower-risk categories at EOT was observed with SZC versus placebo.

CONCLUSIONS:

These analyses expand our knowledge of the spectrum of potassium responses with SZC in hyperkalemic hemodialysis patients.

TRIAL REGISTRATION:

NCT03303521 .

• Authors: Steven Fishbane, Martin Ford, Masafumi Fukagawa, Kieran McCafferty, Anjay Rastogi, Bruce Spinowitz, Konstantin Staroselskiy, Konstantin Vishnevskiy, Vera Lisovskaja, Ayman Al-Shurbaji, Nicolas Guzman, Sunil Bhandari
• Journal: BMC nephrology (BMC Nephrol) Vol. 23 Issue 1 Pg. 59 (02 08 2022) ISSN: 1471-2369 [Electronic] England
• PMID: 35135481 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2022. The Author(s).

Chemical References

• Dialysis Solutions
• Ion Exchange Resins
• Silicates
• sodium zirconium cyclosilicate
• Potassium

Topics

• Dialysis Solutions (analysis)
• Double-Blind Method
• Female
• Humans
• Hyperkalemia (blood, drug therapy)
• Ion Exchange Resins (therapeutic use)
• Kidney Failure, Chronic (blood, complications, therapy)
• Male
• Middle Aged
• Potassium (analysis, blood)
• Renal Dialysis
• Silicates (therapeutic use)