兰州大学机构库
DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients
2023-07
Online publication date2023-08
Source PublicationCLINICAL THERAPEUTICS   Impact Factor & Quartile
ISSN0149-2918 ; 1879-114X
Volume45Issue:7Pages:633-642
page numbers10
AbstractPurpose: The DIALIZE China study (Reduce Incidence of Pre-Dialysis Hyperkalaemia With Sodium Zirconium Cyclosilicate in Chinese Subjects) (NCT04217590) evaluated sodium zirconium cyclosilicate (SZC) for the management of hyperkalemia in Chinese patients undergoing hemodialysis.Methods: In the double-blind, Phase IIIb DIALIZE China study, Chinese adults with kidney failure and predialysis hyperkalemia (predialysis serum potassium [sK +] concentration > 5.4 mmol/L after the long interdialytic interval [LIDI] and > 5.0 mmol/L after =1 short interdialytic interval) who were receiving hemodialysis 3 times weekly were randomized to placebo or SZC 5 g once daily on nondialysis days. Doses were titrated towards maintaining normokalemia for 4 weeks (titration period) in 5-g increments up to 15 g. Primary efficacy was the proportion of responders during the 4-week evaluation period following the titration period (ie, those with a predialysis sK+ of 4.0-5.0 mmol/L for at least 3 of 4 hemodialysis visits following the LIDI) who did not require urgent rescue therapy.Findings: Overall, 134 adults (mean [SD] age, 55 [11.3] years) were randomized to SZC or placebo (n = 67 each). There were significantly more responders with SZC (37.3%) versus placebo (10.4%; estimated odds ratio [OR] = 5.10; 95% CI, 1.90-15.12; P < 0.001). The probability of all predialysis sK+ concentrations being 3.5 to 5.5 mmol/L was significantly higher with SZC versus placebo (estimated OR = 6.41; 95% CI, 2.71-15.12; P < 0.001). A greater proportion of patients achieved an sK+ of 3.5 to 5.5 mmol/L on at least 3 of 4 LIDI visits during evaluation with SZC (73.1%) versus placebo (29.9%). Serious adverse events occurred in 9.1% and 11.9% of patients in the SZC and placebo groups, respectively.Implications: SZC treatment for predialysis hyperkalemia is effective and well tolerated in Chinese patients with kidney failure receiving hemodialysis. ClinicalTrials.gov identifier: NCT04217590.
KeywordDIALIZE dialysis hyperkalemia sodium zirconium cyclosilicate
PublisherELSEVIER
DOI10.1016/j.clinthera.2023.04.014
Indexed BySCIE
Language英语
WOS Research AreaPharmacology & Pharmacy
WOS SubjectPharmacology & Pharmacy
WOS IDWOS:001071768600001
Original Document TypeArticle
PMID 37385905
Citation statistics
Document Type期刊论文
Identifierhttps://ir.lzu.edu.cn/handle/262010/568238
Collection兰州大学
Corresponding AuthorNi, Zhaohui
Affiliation
1.Shanghai Jiao Tong Univ, Ren Ji Hosp, Sch Med, Shanghai, Peoples R China;
2.Cent Hosp Minhang Dist, Shanghai, Peoples R China;
3.Ningbo First Hosp, Ningbo, Peoples R China;
4.Wenzhou Med Univ, Affiliated Hosp 2, Wenzhou, Peoples R China;
5.Nanjing Med Univ, Affiliated Hosp 2, Nanjing, Peoples R China;
6.Univ Chinese Acad Sci, Ningbo Huamei Hosp, Ningbo, Peoples R China;
7.Ningxia Med Univ, Gen Hosp, Yinchuan, Peoples R China;
8.Wenzhou Coll, Affiliated Hosp 1, Wenzhou, Peoples R China;
9.Baotou City Cent Hosp, Baotou, Peoples R China;
10.Inner Mongolia Peoples Hosp, Hohhot, Peoples R China;
11.Zhejiang Tradit Chinese Med Hosp, Hangzhou, Peoples R China;
12.Peoples Hosp Xinjiang Uygur Autonomous Reg, Urumqi, Xinjiang, Peoples R China;
13.Shanghai Gen Hosp, Shanghai, Peoples R China;
14.Dongguan Peoples Hosp, Dongguan, Peoples R China;
15.Shanghai Yangpu Dist Cent Hosp, Shanghai, Peoples R China;
16.Lanzhou Univ, Hosp 2, Lanzhou, Peoples R China;
17.Shenzhen Peoples Hosp, Shenzhen, Peoples R China;
18.Peking Univ, Peoples Hosp, Beijing, Peoples R China;
19.AstraZeneca, Global R&D China, Shanghai, Peoples R China;
20.AstraZeneca, Global R&D China, Beijing, Peoples R China;
21.AstraZeneca R&D, BioPharmaceut Clin, Gaithersburg, MD USA;
22.AstraZeneca R&D, BioPharmaceut Clin, Gothenburg, Sweden;
23.Shanghai Jiao Tong Univ, Ren Ji Hosp, Sch Med, Dept Nephrol, 1630 Dongfang Rd, Shanghai, Peoples R China
Recommended Citation
GB/T 7714
Ni, Zhaohui,Lu, Renhua,Xu, Xudong,et al. DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients[J]. CLINICAL THERAPEUTICS,2023,45(7):633-642.
APA Ni, Zhaohui.,Lu, Renhua.,Xu, Xudong.,Bian, Xueyan.,Zhou, Zhihong.,...&DIALIZE China Study Grp.(2023).DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients.CLINICAL THERAPEUTICS,45(7),633-642.
MLA Ni, Zhaohui,et al."DIALIZE China: A Phase IIIb, Randomized, Placebo-Controlled Study to Reduce Predialysis Hyperkalemia With Sodium Zirconium Cyclosilicate in Chinese Patients".CLINICAL THERAPEUTICS 45.7(2023):633-642.
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