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Enrolling By Invitation
NCT07210021
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Conditions: Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: AccurKardia, Inc.
Location: Central Jersey Kidney Care - Hypertension & Nephrology Associates Eatontown New Jersey
Summary
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.
Eligibility Criteria
Inclusion Criteria:
(Arm 2A - Outpatient Diagnostic Accuracy)
* Age 22 years or older
* CKD stages III-IV managed at Central Jersey Kidney Care outpatient clinic
* Scheduled outpatient serum potassium laboratory test
* On RAASi therapy or documented hyperkalemia (K+ ≥ 5.5 mmol/L) within the past 12 months
* Able to provide written informed consent
(Arm 2B - Remote Patient Monitoring)
* Completion of Arm 2A visit
* Owns an iPhone compatible with the study application
Exclusion Criteria (Both arms):
* Age 21 years or younger
* Pacemaker or implantable cardioverter defibrillator
* Pre existing Left Bundle Branch Block (LBBB), Right Bundle Branch Block (RBBB), Intraventricular Conduction Delay (IVCD), or clinically significant hypocalcemia
* Potassium lowering treatment administered before Lead I ECG acquisition
* Trauma, acute events, or active interventions altering potassium homeostasis
* Physical limitation precluding ECG acquisition
Source: ClinicalTrials.gov (NCT07210021). StuddyBuddy aggregates publicly available trial information.