Hyperkalemia Quality Improvement Program (HK-QIP) Study
A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients
AstraZeneca
1,000 participants
Jun 25, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria12
- 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.
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.
Locations(49)
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NCT06884267