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NCT03635606 · ClinicalTrials.gov registry record

GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients

A clinical trial of Coronary Artery Disease, sponsored by Sapere Bio.

Completed
Registry status
370
Enrollment target
3
Study locations

NCT03635606 is a study of Coronary Artery Disease that has completed, run by Sapere Bio. The registered enrollment target is 370 participants, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (71% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT03635606, a study of Coronary Artery Disease, has completed, sponsored by Sapere Bio.

COMPLETED
Registry status
370 participants
Enrollment target
3
Study locations

Study Summary

Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes. The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.

Conditions Studied

Coronary Artery Disease

Study Locations (3)

California

  • Hoag Memorial Hospital Presbyterian - Newport Beach

Maryland

  • Johns Hopkins University - Baltimore

North Carolina

  • WakeMed Health and Hospitals - Raleigh

Trial Details

FieldValue
Enrollment Target 370 participants
Start Date 2020-02-24
Est. Completion 2023-02-28

Sponsor

Sapere Bio

5 total trials

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What the Registry Record Tells You About NCT03635606

The ClinicalTrials.gov registry entry for NCT03635606 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,285-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (71% lower). The listed sponsor is Sapere Bio, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 0 interventions.

NCT03635606 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Maryland, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03635606 about?

NCT03635606 is a clinical study titled "GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients". Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at...

What is the current status of trial NCT03635606?

This trial is currently completed. The enrollment target is 370 participants. The study started on 2020-02-24. Estimated completion is 2023-02-28.

What conditions does trial NCT03635606 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

Who is sponsoring clinical trial NCT03635606?

This trial is sponsored by Sapere Bio, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03635606 being conducted?

This trial has 3 study locations across California, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.