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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: Recruiting study of Hyperkalemia and Chronic Kidney Disease (Stage 3-4), sponsored by AccurKardia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Defined as serum K+ ≥ 6.5 mmol/L
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 |
What NCT07210021 shows while recruiting
NCT07210021 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 56-participant average among 8 other Hyperkalemia trials with a reported enrollment target (11% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hyperkalemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07210021's enrollment target sits among peer trials
50 4th of 8 higher than 5 of 8 other Hyperkalemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperkalemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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