AK+ Guard™ for Chronic Kidney Disease Monitoring
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Recruiting
Observational Study
Hyperkalemia
Chronic Kidney Disease (Stage 3-4)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 50 (estimated)
- Sponsor
- AccurKardia, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with chronic kidney disease to test a new software that helps detect high potassium levels. Participants will have their potassium levels checked and use the software at home for a month.
Are You a Good Fit for This Trial?
You may be able to join if
- I am 22 years or older
- I have been diagnosed with chronic kidney disease stages III or IV
- I have a scheduled potassium test at the clinic
- I have been treated with RAAS inhibitors or had high potassium in the last year
- I can give my written consent
You may not be able to join if
- I am 21 years old or younger
- I have a pacemaker or implantable defibrillator
- I have a history of certain heart block conditions
- I have had potassium-lowering treatment before my ECG test
- I have had recent trauma or significant medical events
- I have physical limitations that prevent me from getting an ECG
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 …
Trial Locations
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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 1…
Contacts