AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monit… (NCT07210021) | Clinical Trial Compass
RecruitingNot Applicable
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
United States50 participantsStarted 2025-10-14
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L
Timeframe: Baseline (Day 0)
2
Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs)
Timeframe: Daily monitoring up to 4 weeks (Day 28)
3
Arm 2B: (b) Mean System Usability Scale (SUS) score