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NGAL As An Aid for the Diagnosis of Acute Kidney Injury in Intensive Care
NCT02121470 · View on ClinicalTrials.gov ↗
Study Summary
Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients which is associated with increased morbidity and mortality as well as high costs of medical care. NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker, that is expressed in several tissues including the kidneys. Renal expression of NGAL is dramatically increased in kidney injury from a variety of causes, and NGAL is released into both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early and sensitive biomarker of kidney injury, with the potential to assist clinicians in managing patients at risk of kidney injury. This study is designed to validate the assigned NGAL cutoff value by comparing to clinical diagnosis of AKI as determined by current clinical practice in the US. The study sites will enroll consecutive ICU patients. Patients are given standard clinical care and lab-work. Each day, one additional urine and two additional plasma samples will be drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL measurements. The duration of each subject´s participation will be until discharge from the ICU, or for a maximum 8 days, whichever comes first. In addition serum creatinine values will continue to be collected manually from the hospital data system for 48 hours after discharge from the ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected while the patient is still in the ICU). 250 subjects will be enrolled in total at the three investigator sites. At least 40 patients must be enrolled at each site. The NGAL value will be matched to the "clinical diagnosis" of acute kidney injury (AKI) as specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are blinded for investigation site, AKI-diagnosis by treating physician
Conditions Studied
Study Locations (4)
Massachusetts
- Massachusetts General Hospital — Boston
- Baystate Medical Center / WNERTA — Springfield
New York
- Montefiore Medical Center — The Bronx
Texas
- Methodist Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 252 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02121470
The ClinicalTrials.gov registry entry for NCT02121470 describes a study currently listed as completed. 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 252 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioPorto Diagnostics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Acute Kidney Injury appearing as the primary indexed condition, and to 0 interventions. 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: NCT02121470 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Massachusetts, New York, Texas. 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 NCT02121470 about?
NCT02121470 is a clinical study titled "NGAL As An Aid for the Diagnosis of Acute Kidney Injury in Intensive Care". Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients which is associated with increased morbidity and mortality as well as high costs of medical care. NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker, that is expressed in...
What is the current status of trial NCT02121470?
This trial is currently completed. The enrollment target is 252 participants. The study started on 2014-02. Estimated completion is 2015-06.
What conditions does trial NCT02121470 study?
This clinical trial studies the following conditions: Acute Kidney Injury. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02121470?
This trial is sponsored by BioPorto Diagnostics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02121470 being conducted?
This trial has 4 study locations across Massachusetts, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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