Hyperkalemia Quality Improvement Program (HK-QIP) Study

Launched by ASTRAZENECA · Mar 13, 2025

Keywords

ClinConnect Summary

The Hyperkalemia Quality Improvement Program (HK-QIP) Study is a research project designed to improve the treatment of high potassium levels (hyperkalemia) in patients with chronic kidney disease who are not on dialysis. The study will look at how following certain medical guidelines can help manage hyperkalemia better in these patients, especially using a specific type of medication called RAAS inhibitors. The goal is to gather evidence that can lead to better care for patients with chronic kidney disease in China.

To participate in this study, individuals need to be at least 18 years old and have high potassium levels (above 5.0 mmol/L) within 48 hours before joining. They should also have chronic kidney disease with a specific level of kidney function. However, people who are on dialysis, have certain serious medical conditions, or have a life expectancy of less than a year will not be eligible. If someone chooses to participate, they will receive treatment according to the study's guidelines and will be monitored closely for their health throughout the trial. This study is not yet recruiting participants, so it is still in the planning stages.

Gender

ALL

Eligibility criteria

• 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.