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NCT02182440 · ClinicalTrials.gov registry record · Phase 2
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
A Phase 2 study of Acute Kidney Injury, sponsored by AM-Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 301
- Enrollment target
- 20
- Study locations
NCT02182440: Completed Phase 2 study of Acute Kidney Injury, sponsored by AM-Pharma.
NCT02182440 is a Phase 2 study of Acute Kidney Injury that has completed, run by AM-Pharma. The registered enrollment target is 301 participants, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02182440, a Phase 2 study of Acute Kidney Injury, has completed, sponsored by AM-Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 301 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Primary endpoint is calculated as the average of the standardized endogenous creatinine clearance values over the first seven days between the placebo and 1.6 mg/kg recAP arm. Standardized endogenous creatinine clearance is assessed on each days from D1 to Day 7 during a 6 +/- 1 hour period and calculated in mL/min as the mean creatinine clearance over the period. The study started with 4 treatment arms of which 0.4 mg/kg recAP and the 0.8 mg/kg recAP were dropped after the interim analysis. Th
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 |
What the finished NCT02182440 record still lists
NCT02182440 is an interventional study that assigns participants to a tested intervention. The registered 301 participants enrollment target is mid-sized for trials with a published cap, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower).
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.
NCT02182440 names 20 study sites across 12 states, led by Other, Tyrol, Alabama.
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.
What interventions are being tested in trial NCT02182440?
The interventions under investigation include: Placebo (OTHER), recAP (BIOLOGICAL).
Who is sponsoring clinical trial NCT02182440?
This trial is sponsored by AM-Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Acute Kidney Injury
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 NCT02182440's enrollment target sits among peer trials
301 24th of 74 higher than 51 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury 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.
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