Correction of serum potassium with sodium zirconium cyclosilicate in Japanese patients with hyperkalemia: a randomized, dose-response, phase 2/3 study.
Hyperkalemia
Japan
Japanese
Sodium zirconium cyclosilicate
Journal
Clinical and experimental nephrology
ISSN: 1437-7799
Titre abrégé: Clin Exp Nephrol
Pays: Japan
ID NLM: 9709923
Informations de publication
Date de publication:
Dec 2020
Dec 2020
Historique:
received:
29
04
2020
accepted:
19
07
2020
pubmed:
12
8
2020
medline:
25
8
2021
entrez:
12
8
2020
Statut:
ppublish
Résumé
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 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 SZC is effective and well tolerated in Japanese patients with hyperkalemia.
Sections du résumé
BACKGROUND
BACKGROUND
Sodium zirconium cyclosilicate (SZC) is an oral potassium binder approved to treat hyperkalemia in adults in a number of countries, including Japan.
METHODS
METHODS
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
RESULTS
RESULTS
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
CONCLUSION
CONCLUSIONS
SZC is effective and well tolerated in Japanese patients with hyperkalemia.
Identifiants
pubmed: 32779057
doi: 10.1007/s10157-020-01937-1
pii: 10.1007/s10157-020-01937-1
pmc: PMC7599176
doi:
Substances chimiques
Biomarkers
0
Chelating Agents
0
Silicates
0
sodium zirconium cyclosilicate
D652ZWF066
Potassium
RWP5GA015D
Banques de données
ClinicalTrials.gov
['NCT03127644']
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1144-1153Références
JAMA. 2012 Jan 11;307(2):157-64
pubmed: 22235086
Acad Emerg Med. 2020 Jun;27(6):475-486
pubmed: 32149451
Am J Med. 2013 Mar;126(3):264.e9-24
pubmed: 23321430
J Nephrol. 2015 Apr;28(2):165-72
pubmed: 24990164
Am J Cardiol. 2012 May 15;109(10):1510-3
pubmed: 22342847
Clin J Am Soc Nephrol. 2019 Jun 7;14(6):798-809
pubmed: 31110051
J Emerg Med. 2004 Aug;27(2):153-60
pubmed: 15261358
Am J Emerg Med. 2000 Oct;18(6):721-9
pubmed: 11043630
JAMA. 2014 Dec 3;312(21):2223-33
pubmed: 25402495
Kidney Int. 2015 Aug;88(2):404-11
pubmed: 25651363
Intern Med. 2007;46(12):823-9
pubmed: 17575373
PLoS One. 2014 Dec 22;9(12):e114686
pubmed: 25531770
Rev Esp Enferm Dig. 2013 Apr;105(4):232-4
pubmed: 23859454
N Engl J Med. 2004 Aug 5;351(6):543-51
pubmed: 15295047
Drugs R D. 2018 Sep;18(3):231-235
pubmed: 30097847
Clin J Am Soc Nephrol. 2017 Feb 7;12(2):245-252
pubmed: 28143865
Am J Nephrol. 2017;46(3):213-221
pubmed: 28866674
PLoS One. 2017 Sep 6;12(9):e0184402
pubmed: 28877239
Eur J Heart Fail. 2015 Oct;17(10):1050-6
pubmed: 26011677
Crit Care. 2012 Nov 21;16(6):R225
pubmed: 23171442
J Hum Hypertens. 2003 Sep;17(9):623-30
pubmed: 13679952
J Am Soc Nephrol. 2019 Sep;30(9):1723-1733
pubmed: 31201218
J Am Soc Nephrol. 2010 May;21(5):733-5
pubmed: 20167700
Drug Saf. 2014 Sep;37(9):677-92
pubmed: 25047526
BMJ Open. 2015 Mar 20;5(3):e006625
pubmed: 25795689
J Med Assoc Thai. 2013 Dec;96(12):1617-20
pubmed: 24511728
Kidney Int Rep. 2019 May 30;4(9):1248-1260
pubmed: 31517144
ESC Heart Fail. 2014 Sep;1(1):4-25
pubmed: 28834669
N Engl J Med. 2015 Jan 15;372(3):222-31
pubmed: 25415807