AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
NCT07210021
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Hyperkalemia
- Chronic Kidney Disease (Stage 3-4)
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- AccurKardia, Inc.
- Last updated on ClinicalTrials.gov
- October 16, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
New Jersey · 1
- Central Jersey Kidney Care - Hypertension & Nephrology Associates · Eatontown, NJ
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.