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| Name | Class |
|---|---|
| Abbott Diagnostics Division | INDUSTRY |
| Alere, Inc. | INDUSTRY |
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AKINESIS is a clinical study to assess the utility of blood and urine NGAL tests in predicting worsening kidney function in patients who present with acute heart failure (AHF) and who are treated with diuretics. It is believed that rising NGAL levels in the blood and/or urine can predict acute kidney injury. It is also believed that patients who are admitted to the hospital with high NGAL levels in the blood/urine will have poorer outcomes.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the Efficacy of the Triage NGAL Test as an Aid to Diagnosis of Acute Kidney Injury (AKI) in Patients Admitted to the Hospital With Symptoms of Acute Heart Failure. | Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1. | First week of hospitalization. |
| Evaluating the Efficacy of the Triage NGAL Test as an Aid in Predicting Poorer Outcomes in Patients Admitted to the Hospital With Admitted With Symptoms of Acute Heart Failure. | Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1. | ~30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be enrolled primarily from hospital emergency rooms located at various academic centers located throughout the USA and Europe.
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| Name | Affiliation | Role |
|---|---|---|
| Alan Maisel, MD | University of California, San Diego Medical Center/Veterans Affairs Medical Center, San Diego | Principal Investigator |
| Patrick Murray, MD | University College of Dublin School of Medicine and Medical Science/Mater Misericordiae University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Medical Center | San Diego | California | 92103 | United States | ||
| San Diego Veterans Administration Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39421939 | Derived | Duff S, Wettersten N, Horiuchi Y, van Veldhuisen DJ, Raturi S, Irwin R, Cote JM, Maisel A, Ix JH, Murray PT. Absence of Kidney Tubular Injury in Patients With Acute Heart Failure With Acute Kidney Injury. Circ Heart Fail. 2024 Nov;17(11):e011751. doi: 10.1161/CIRCHEARTFAILURE.123.011751. Epub 2024 Oct 18. | |
| 27659464 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrollment Group | Subjects with sufficient data to be included in the analysis. |
| FG001 | Subjects Enrolled But Not Included in the Analysis. | Subjects that were consented and some study procedures completed but did not have required study procedures completed and subsequent data available for inclusion in the primary analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Urine Samples, Plasma Samples
| San Diego |
| California |
| 92161 |
| United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Henry Ford Health System | Detroit | Michigan | 48208 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Virginia Commonweath University Medical Center | Richmond | Virginia | 23298 | United States |
| Athens University Hospital Attikon | Athens | 12461 | Greece |
| University Hospital Dublin | Dublin | 4 | Ireland |
| Clinica Mediterranea | Naples | Italy |
| Monasterio Foundation for Medical Research and Public Health | Pisa | Italy |
| University of Groningen Medical Center | Groningen | GZ Groningen | 9713 | Netherlands |
| Hospital Clínico Universitario Valencia | Valencia | Spain |
| Universitätsspital Basel | Basel | Petersgraben | 4 | Switzerland |
| Maisel AS, Wettersten N, van Veldhuisen DJ, Mueller C, Filippatos G, Nowak R, Hogan C, Kontos MC, Cannon CM, Muller GA, Birkhahn R, Clopton P, Taub P, Vilke GM, McDonald K, Mahon N, Nunez J, Briguori C, Passino C, Murray PT. Neutrophil Gelatinase-Associated Lipocalin for Acute Kidney Injury During Acute Heart Failure Hospitalizations: The AKINESIS Study. J Am Coll Cardiol. 2016 Sep 27;68(13):1420-1431. doi: 10.1016/j.jacc.2016.06.055. |
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| NOT COMPLETED |
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ED presentation with symptoms of Heart Failure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrollment Group-No Treatment Arms. | All subjects underwent the same protocol procedures no stratification. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Evaluating the Efficacy of the Triage NGAL Test as an Aid to Diagnosis of Acute Kidney Injury (AKI) in Patients Admitted to the Hospital With Symptoms of Acute Heart Failure. | Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1. | Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol. | Posted | Number | 95% Confidence Interval | Probability classifying AKI from non-AKI | First week of hospitalization. |
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| Primary | Evaluating the Efficacy of the Triage NGAL Test as an Aid in Predicting Poorer Outcomes in Patients Admitted to the Hospital With Admitted With Symptoms of Acute Heart Failure. | Efficacy determined by the evaluation of the area under the Receiver Operator Curve (ROC) generated from the study primary endpoint data. The units on both axes of the ROC curve are dimensionless proportions from 0 to 1. | Participants were enrolled from patients presenting to the ED with signs and/or symptoms of Heart Failure. Subjects also had to meet specific operational requirements for the blood drawing time frame, per the protocol. | Posted | Number | 95% Confidence Interval | Probability classifying AKI from non-AKI | ~30 days |
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~30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrollment Group | Subjects enrolled in the study and completing study procedures required for the analysis. | 0 | 930 | 0 | 930 | ||
| EG001 | Non-participating Group | Subjects consented and/or enrolled in the study but not completing study procedures required for the analysis. | 0 | 71 | 0 | 71 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Arnold | Alere San Diego | 858-505-2000 | william.arnold@alere.com |
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Germany |
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