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NCT07210021 · ClinicalTrials.gov registry record
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
A clinical trial of Hyperkalemia and Chronic Kidney Disease (Stage 3-4), sponsored by AccurKardia.
- Recruiting
- Registry status
- 50
- Enrollment target
- 1
- Study location
NCT07210021 is a study of Hyperkalemia and Chronic Kidney Disease (Stage 3-4) that is actively recruiting participants, run by AccurKardia. The registered enrollment target is 50 participants, below the 56-participant average among 8 other Hyperkalemia trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07210021, a study of Hyperkalemia and Chronic Kidney Disease (Stage 3-4), is actively recruiting participants, sponsored by AccurKardia.
- RECRUITING
- Registry status
- 50 participants
- Enrollment target
- 1
- Study location
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, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 56-participant average among 8 other Hyperkalemia trials with a reported enrollment target (11% lower). The listed sponsor is AccurKardia, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT07210021 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
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).
What interventions are being tested in trial NCT07210021?
The interventions under investigation include: AK+ Guard™ ECG Application (DEVICE).
Who is sponsoring clinical trial NCT07210021?
This trial is sponsored by AccurKardia, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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