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Clinical Trials in China / NCT06884267
Active, not recruiting Not applicable

Hyperkalemia Quality Improvement Program (HK-QIP) Study

NCT06884267 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Not applicable
Started
2025-06-25
Last updated
2026-08-20

Condition(s) studied

Hyperkalemia

Investigational drug(s) / intervention(s)

standard hyperkalemia management implementation

standard hyperkalemia management implementation: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥18 years, at the time of signing the informed consent. 2. HK (sK+ \> 5.0 mmol/L) within 48 hours before enrolment. 3. 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. 4. 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. Exclusion Criteria: 1. Patients on dialysis. 2. 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. 3. Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA). 4. Patients with cardiac arrhythmias that require immediate treatment 5. Patients scheduled for renal transplant or with a history of renal transplant. 6. Life expectancy \< 48 weeks. 7. History of malignancy except for: 7.1 Malignancy treated with curative intent and with no known active disease within 3 years before the enrolment and of low potential risk for recurrence. 7.2 Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease. 7.3 Adequately treated carcinoma in situ without evidence of disease. 8. Be participating in other intervention clinical trials. 9. 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.

Primary outcome measure(s)

Trial sites (49)

FacilityCityRegionStatus
Research Site Beijing China
Research Site Benxi China
Research Site Changchun China
Research Site Changsha China
Research Site Changsha China
Research Site Changsha China
Research Site Chengdu China
Research Site Chengdu China
Research Site Chengdu China
Research Site Chongqing China
Research Site Dalian China
Research Site Fuyang China
Research Site Fuzhou China
Research Site Fuzhou China
Research Site Gejiu China
Research Site Guangzhou China
Research Site Guangzhou China
Research Site Guiyang China
Research Site Haikou China
Research Site Hangzhou China
Research Site Hefei China
Research Site Hohhot China
Research Site Jinan China
Research Site Jinan China
Research Site Kunming China
Research Site Kunming China
Research Site Lanzhou China
Research Site Nanchang China
Research Site Nanning China
Research Site Nantong China
Research Site Ningbo China
Research Site Pingdingshan China
Research Site Qiqihar China
Research Site Shanghai China
Research Site Shanghai China
Research Site Shanghai China
Research Site Shenyang China
Research Site Shijiazhuang China
Research Site Taiyuan China
Research Site Tianjin China

+ 9 more sites — see the full list on the official registry below.

More AstraZeneca trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884267 on ClinicalTrials.gov ↗ ← All trials in China