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AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
NCT07210021 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE AK+ Guard™ ECG Application
Study Locations (1)
New Jersey
- Central Jersey Kidney Care - Hypertension & Nephrology Associates — Eatontown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-10-14 |
| Est. Completion | 2025-11-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07210021
The ClinicalTrials.gov registry entry for NCT07210021 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AccurKardia, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hyperkalemia appearing as the primary indexed condition, and to 1 intervention — of which AK+ Guard™ ECG Application is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07210021 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07210021 about?
NCT07210021 is a clinical study titled "AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring". 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 ...
What is the current status of trial NCT07210021?
This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2025-10-14. Estimated completion is 2025-11-28.
What conditions does trial NCT07210021 study?
This clinical trial studies the following conditions: Hyperkalemia, Chronic Kidney Disease (Stage 3-4). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07210021?
The interventions under investigation include: AK+ Guard™ ECG Application (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07210021?
This trial is sponsored by AccurKardia, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07210021 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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