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NCT04411472 · ClinicalTrials.gov registry record · Phase 3
(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
A Phase 3 study, sponsored by AM-Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 676
- Enrollment target
NCT04411472 is a Phase 3 study that was terminated before completion, run by AM-Pharma. The registered enrollment target is 676 participants.
The verdict
NCT04411472, a Phase 3 study, was terminated before completion, sponsored by AM-Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 676 participants
- Enrollment target
Study Summary
Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis. The study has three distinct SA-AKI trial populations: 1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 2. A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and \<45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization. 3. A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this population, COVID-19 should be the main cause of SA-AKI. In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients. There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.
Interventions
- OTHER Placebo
- BIOLOGICAL Recombinant human alkaline phosphatase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 676 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2022-08-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04411472
The ClinicalTrials.gov registry entry for NCT04411472 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 676 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AM-Pharma, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04411472 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04411472 about?
NCT04411472 is a clinical study titled "(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI". Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis. The study has three distinct SA-AKI trial populations: 1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1....
What is the current status of trial NCT04411472?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 676 participants. The study started on 2020-11-02. Estimated completion is 2022-08-18.
What interventions are being tested in trial NCT04411472?
The interventions under investigation include: Placebo (OTHER), Recombinant human alkaline phosphatase (BIOLOGICAL).
Who is sponsoring clinical trial NCT04411472?
This trial is sponsored by AM-Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
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