AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Recruiting now
Conditions studied: Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
In brief
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.
Key facts
- Study ID
- NCT07210021
- Run by
- AccurKardia, Inc.
- People needed
- 50
- Starts
- 2025-10-14
- Expected to finish
- 2025-11-28
- Last updated by the study team
- 2025-10-16
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (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
Where it is running
- Central Jersey Kidney Care - Hypertension & Nephrology Associates — Eatontown, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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