Active — Not RecruitingNot Applicable

Hyperkalemia Quality Improvement Program (HK-QIP) Study

China1,000 participantsStarted 2025-06-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

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.

Timeframe: Week 48

Trial details

NCT IDNCT06884267

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-11

View on ClinicalTrials.gov More Hyperkalemia trials