Status:
RECRUITING
Hyperkalemia Quality Improvement Program (HK-QIP) Study
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 ki...
Detailed Description
This is a multi-center, prospective, single-arm interventional study to evaluate the impact on the implementation of standardized hyperkalemia management in CKD patients. Essentially, this is a qualit...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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.
- 2 Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.
- 3 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.
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 3 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06884267
Start Date
June 25 2025
End Date
November 3 2027
Last Update
December 9 2025
Active Locations (2)
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1
Research Site
Shanghai, China, 200032
2
Research Site
Shanghai, China, 200233