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A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
NCT02182440 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL recAP
Study Locations (20)
Other
- University Hospital Antwerpen — Antwerp
- Cliniques Universitaires Saint Luc-UCL — Brussels
- CHU Brugmann — Brussels
- UZ Brussel — Brussels
- Oblastni nemocnice Kolin, a.s. — Kolín
- Fakultni nemocnice Plzen — Pilsen
- Helsingin Yliopistollinen Keskussairaala — Helsinki
- Kuopion Yliopistollinen Sairaala — Kuopio
Tyrol
- Medizinische Universität Innsbruck — Innsbruck
- Universitätsklinik für Allgemeine und Chirurgische Intensivmedizin — Innsbruck
Alabama
- University of Alabama at Birmingham — Birmingham
Florida
- Tampa General Hospital, Division Emergency Medicine — Tampa
Idaho
- Eastern Idaho Medical Consultants LLC — Idaho Falls
Ohio
- University of Cincinnati Medical Center — Cincinnati
Pennsylvania
- UPMC — Pittsburgh
Texas
- University of Texas Houston Medical School — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2014-12-18 |
| Est. Completion | 2017-09-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02182440
The ClinicalTrials.gov registry entry for NCT02182440 describes a study currently listed as completed. It is categorized as Phase 2, 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 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AM-Pharma, which has 1 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 2 interventions — of which Placebo is the first listed. 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: NCT02182440 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Tyrol, Alabama. 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 NCT02182440 about?
NCT02182440 is a clinical study titled "A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI". The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
What is the current status of trial NCT02182440?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 301 participants. The study started on 2014-12-18. Estimated completion is 2017-09-27.
What conditions does trial NCT02182440 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.
What interventions are being tested in trial NCT02182440?
The interventions under investigation include: Placebo (OTHER), recAP (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02182440?
This trial is sponsored by AM-Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02182440 being conducted?
This trial has 20 study locations across Alabama, Florida, Idaho, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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