(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
Public ClinicalTrials.gov record NCT04411472. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04411472
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 676 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 1, 2020
- Primary completion
- Aug 17, 2022
- Completion
- Aug 17, 2022
- Last update posted
- Jun 2, 2024
2020 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724-5057 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095-8358 | — |
| The George Washington University Medical Faculty Associates - Anesthesiology | Washington D.C. | District of Columbia | 20037-2342 | — |
| Emory Clinical Cardiovascular Research Institute | Atlanta | Georgia | 30322-1007 | — |
| Glenbrook Hospital | Glenview | Illinois | 60026-1301 | — |
| NorthShore Medical Group - Bannockburn | Highland Park | Illinois | 60035 | — |
| University of Kentucky College of Medicine (UKCM) | Lexington | Kentucky | 40508-3215 | — |
| Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| University of New Mexico School of Medicine | Albuquerque | New Mexico | 87131 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45219 | — |
| The Ohio State University - Dorothy M. Davis Heart and Lung Research Institute | Columbus | Ohio | 43210 | — |
| UPMC CancerCenter at Magee - Womens Hospital | Pittsburgh | Pennsylvania | 15213-3108 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213-3108 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908-0817 | — |
| Froedtert & the Medical College of Wisconsin Froedtert Hospital | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 106 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04411472, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2024 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04411472 live on ClinicalTrials.gov.