Abstract: FR-PO651
Efficacy and Safety of Sodium Zirconium Cyclosilicate for Reducing the Incidence of Hyperkalemia in Patients with ESRD: A Japanese Subgroup Analysis of the DIALIZE Study
Session Information
- Fluid and Electrolytes: Clinical - Potassium, Sodium, Water
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Fluid and Electrolytes
- 902 Fluid and Electrolytes: Clinical
Authors
- Fukagawa, Masafumi, Tokai University School of Medicine, Isehara-shi, Kanagawa, Japan
- Fishbane, Steven, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States
- Iitsuka, Tadashi, Ibaraki Seinan Medical Center Hospital, Ibaraki, Japan
- Suda, Akio, Hakusuikai Suda Clinic, Shinjuku-ku, Tokyo, Japan
- Al-shurbaji, Ayman, AstraZeneca, Gothenburg, Sweden
- Guzman, Nicolas Jose, AstraZeneca, Gaithersburg, Maryland, United States
- Lisovskaja, Vera, AstraZeneca, Gothenburg, Sweden
- Yajima, Toshitaka, AstraZeneca K.K., Tokyo, Japan
- Sarai, Nobuaki, AstraZeneca K.K., Tokyo, Japan
Background
Patients with end-stage renal disease (ESRD) are at increased risk of developing hyperkalemia (HK), despite receiving hemodialysis (HD), even if with use of lower dialysate potassium concentration (2.0mEq/L). DIALIZE (NCT03303521), a randomized, double-blind, placebo (PBO)-controlled, phase 3b, international study, determined the efficacy and safety of sodium zirconium cyclosilicate (SZC) for the treatment of HK in ESRD patients undergoing HD. Here, we report an exploratory analysis of the Japanese subgroup.
Methods
Patients were adults on stable HD with HK, and were randomly assigned (1:1) to receive PBO or SZC. Study drugs were administered orally, starting at a dose of 5g once daily on non-dialysis days and titrated at 5g increments to a maximum of 15g daily, to maintain normokalemia (serum K: 4.0-5.0mmol/L). Primary endpoint was the proportion of responders (i.e., patients who maintained a pre-dialysis serum K between 4.0 and 5.0mmol/L on at least 3/4 dialysis treatments after a long inter-dialytic interval without requiring rescue therapy during the evaluation period), and secondary was the proportion of patients requiring rescue therapy for severe HK. Adverse events and inter-dialytic weight gain (IDWG) were evaluated for safety.
Results
A total of 56 Japanese patients were randomly assigned: 28 received SZC, and 28 PBO; 96.4% completed the study in the SZC group and 100% in the PBO group. Patients in the SZC and PBO groups had a mean age of 60.7 and 64.4 years, respectively; all other baseline characteristics were balanced between groups. 71.4% (n=20) and 0% were responders (nominal p<.001) in the SZC and placebo group, respectively. Further, 3 subjects in the placebo group but none on SZC required rescue therapy. AEs were reported in 53.6% (n=15) and 57.1% (n=16). Two SAEs were reported, one in SZC group (gastrointestinal hemorrhage) and one in placebo group (arteriovenous fistula site complication); both events were deemed unrelated to the study drug. IDWG was similar in both groups.
Conclusion
This exploratory analysis showed that the safety and efficacy profile of SZC in the Japanese subgroup is in line with that observed in the global study population.
Funding
- Commercial Support –