Hyperkalemia Quality Improvement Program (HK-QIP) Study
HK-QIP
A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients
1 other identifier
interventional
1,000
1 country
49
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Typical duration for not_applicable
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedStudy Start
First participant enrolled
June 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 3, 2027
March 9, 2026
March 1, 2026
2.4 years
March 13, 2025
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients who achieve RAASi optimizationa with normal sK+ level (3.5 mmol/L ≤ sK+ ≤5.0 mmol/L) after 48 weeks intervention.
To describe the effectiveness of standardized management in patients with CKD and HK for achievement of sK+ control and RAASi optimization
Week 48
Secondary Outcomes (3)
The proportion of patients with normal sK+ level 3.5 mmol/L≤ sK+ ≤ 5.0 mmol/L at each onsite visit.
Week12，Week24，Week36，Week48，Week72，Week96
The proportion of patients who achieve RAASi optimization with normal sK+ level (3.5 mmol/L ≤ sK+ ≤ 5.0 mmol/L) after 12 weeks and 24 weeks intervention.
Week12，Week24
Percentage change in UACR from baseline to week 48 and week 96 in patients with RAASi use at baseline.
Week48，Week96
Study Arms (1)
one arm without control group
OTHERThis 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.
Interventions
The interventions include HK disease management and quality audits for health care professionals (HCPs) and patients (Figure 1). The main contents of HK disease management in CKD include a standardized clinical pathway based on guideline adoption and medical trainings to educate HCPs and patients.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients on dialysis.
- Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
- Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA).
- Patients with cardiac arrhythmias that require immediate treatment
- Patients scheduled for renal transplant or with a history of renal transplant.
- Life expectancy \< 48 weeks.
- History of malignancy except for:
- Malignancy treated with curative intent and with no known active disease within 3 years before the enrolment and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Be participating in other intervention clinical trials.
- Judgment by the HCP that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (49)
Research Site
Beijing, 100029, China
Research Site
Benxi, 117000, China
Research Site
Changchun, 130041, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410013, China
Research Site
Changsha, 410300, China
Research Site
Chengdu, 610031, China
Research Site
Chengdu, 610041, China
Research Site
Chengdu, 610078, China
Research Site
Chongqing, 400042, China
Research Site
Dalian, 116023, China
Research Site
Fuyang, 236600, China
Research Site
Fuzhou, 350005, China
Research Site
Fuzhou, 350031, China
Research Site
Gejiu, 661099, China
Research Site
Guangzhou, 510280, China
Research Site
Guangzhou, 510530, China
Research Site
Guiyang, 510630, China
Research Site
Haikou, 570311, China
Research Site
Hangzhou, 310006, China
Research Site
Hefei, 230001, China
Research Site
Hohhot, 10050, China
Research Site
Jinan, 250012, China
Research Site
Jinan, 250021, China
Research Site
Kunming, 650021, China
Research Site
Kunming, 650101, China
Research Site
Lanzhou, 730030, China
Research Site
Nanchang, 330006, China
Research Site
Nanning, 530021, China
Research Site
Nantong, 226001, China
Research Site
Ningbo, 315010, China
Research Site
Pingdingshan, 467000, China
Research Site
Qiqihar, 161000, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200233, China
Research Site
Shenyang, 110001, China
Research Site
Shijiazhuang, 50051, China
Research Site
Taiyuan, 030001, China
Research Site
Tianjin, 300192, China
Research Site
Ürümqi, 830054, China
Research Site
Wuhan, 430022, China
Research Site
Wuhu, 241000, China
Research Site
Wuxi, 214062, China
Research Site
Xi'an, 710061, China
Research Site
Xining, 810001, China
Research Site
Xinxiang, 453100, China
Research Site
Yinchuan, 750004, China
Research Site
Zhengzhou, 450003, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoqiang Ding
Fudan University
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2025
First Posted
March 19, 2025
Study Start
June 25, 2025
Primary Completion (Estimated)
November 3, 2027
Study Completion (Estimated)
November 3, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.