A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients
Status: Recruiting
Location: See all (49) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective, multi-center, single-arm study to evaluate the impact of implementation of guideline determined medical therapy (GDMT) for quality control improvement in non-dialysis chronic kidney disease (CKD-ND) patients, as well as provide evidence for standard hyperkalemia management with RAASi optimization in China CKD-ND patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years, at the time of signing the informed consent.
• HK (sK+ \> 5.0 mmol/L) within 48 hours before enrolment.
• Patients diagnosed as chronic kidney disease with eGFR\>10 ml/min/1.73m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021). See 8.3.4 for detailed equation.
• Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Locations
Other Locations
China
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Beijing
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Benxi
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Changchun
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Changsha
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Changsha
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Changsha
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Chengdu
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Chengdu
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Chengdu
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Chongqing
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Dalian
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Fuyang
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Fuzhou
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Fuzhou
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Gejiu
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Guangzhou
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Guangzhou
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Guiyang
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Haikou
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Hangzhou
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Hefei
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Hohhot
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Jinan
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Jinan
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Kunming
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Kunming
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Lanzhou
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Nanchang
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Nanning
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Nantong
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Ningbo
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Pingdingshan
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Qiqihar
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Shanghai
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Shanghai
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Shanghai
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Shenyang
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Shijiazhuang
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Taiyuan
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Tianjin
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Ürümqi
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Wuhan
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Wuhu
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Wuxi
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Xi'an
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Xining
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Xinxiang
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Yinchuan
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Zhengzhou
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2025-06-25
Estimated Completion Date:2027-11-03
Participants
Target number of participants:1000
Treatments
Other: one arm without control group
This is a single-arm interventional study.This study will enroll 1,000 adult Chinese patients with non-dialysis chronic kidney disease (CKD-ND) and HK from around 50 sites in China.