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Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.

Authors
  • Kashihara, Naoki1
  • Nishio, Toshiki2
  • Osonoi, Takeshi3
  • Saka, Yosuke4
  • Imasawa, Toshiyuki5
  • Ohtake, Takayasu6
  • Mizuno, Hiroshi7
  • Shibagaki, Yugo8
  • Kim, Hyosung9
  • Yajima, Toshitaka9
  • Sarai, Nobuaki10
  • 1 Department of Nephrology and Hypertension, Kawasaki Medical School, Okayama, Japan. , (Japan)
  • 2 Nephrology Dialysis Center, Kusatsu General Hospital, Shiga, Japan. , (Japan)
  • 3 Department of Internal Medicine, Nakakinen Clinic, Ibaraki, Japan. , (Japan)
  • 4 Department of Nephrology, Kasugai Municipal Hospital, Aichi, Japan. , (Japan)
  • 5 Department of Nephrology, Chiba-Higashi Hospital, Chiba, Japan. , (Japan)
  • 6 Department of Nephrology, Shonan Kamakura General Hospital, Kanagawa, Japan. , (Japan)
  • 7 Department of Nephrology, Inage Hospital, Chiba, Japan. , (Japan)
  • 8 Division of Nephrology and Hypertension, St. Marianna University School of Medicine Hospital, Kanagawa, Japan. , (Japan)
  • 9 Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan. , (Japan)
  • 10 Research and Development, AstraZeneca K.K, 1-8-3, Marunouchi, Chiyoda-ku, Tokyo, 100-0005, Japan. [email protected] , (Japan)
Type
Published Article
Journal
Clinical and experimental nephrology
Publication Date
Aug 10, 2020
Identifiers
DOI: 10.1007/s10157-020-01937-1
PMID: 32779057
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan. This phase 2/3, randomized, double-blind, placebo-controlled, dose-response study (ClinicalTrials.gov: NCT03127644) was designed to determine the efficacy and safety of SZC in Japanese adults with hyperkalemia. Patients with serum potassium (sK+) concentrations ≥ 5.1- ≤ 6.5 mmol/L were randomized 1:1:1 to SZC 5 g, SZC 10 g, or placebo three times daily for 48 h (six doses total). The primary efficacy endpoint was the exponential rate of change in sK+ over 48 h. The proportion of patients with normokalemia (sK+ 3.5-5.0 mmol/L) at 48 h and adverse events (AEs) were also evaluated. Overall, 103 patients (mean age, 73.2 years; range 50-89 years) received SZC 5 g (n = 34), SZC 10 g (n = 36), or placebo (n = 33). The exponential rate of sK+ change from 0 to 48 h versus placebo was - 0.00261 (SZC 5 g) and - 0.00496 (SZC 10 g; both P < 0.0001). At 48 h, the proportions of patients with normokalemia were 85.3%, 91.7%, and 15.2% with SZC 5 g, SZC 10 g, and placebo, respectively. No serious AEs were reported. Hypokalemia (sK+ < 3.5 mmol/L) occurred in two patients in the SZC 10 g group; normokalemia was re-established within 6 days and no treatment-related AEs were reported. SZC is effective and well tolerated in Japanese patients with hyperkalemia.

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