Condition: Hyperkalemia · Chronic Kidney Disease (Stage 3-4) · Sponsor: AccurKardia, Inc.
The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD). Study objectives are: * Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw. * Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.
This description comes directly from the study's public registry record.
Moin Hussaini · 718-708-3522 · mhussaini@accurkardia.com
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| Central Jersey Kidney Care - Hypertension & Nephrology Associates | Eatontown, New Jersey, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07210021