(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With S… (NCT04411472) | Clinical Trial Compass
TerminatedPhase 3
(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
Stopped: The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern.
United States676 participantsStarted 2020-11-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years or older.
✓. In the ICU or intermediate care unit for clinical reasons.
✓. Have sepsis requiring vasopressor (norepinephrine, epinephrine, dopamine, phenylephrine, vasopressin, or angiotensin II) therapy, i.e.:
✓. suspected or proven bacterial or viral infection. and
✓. on vasopressor therapy (≥0.1 µg/kg/min norepinephrine or equivalent) for sepsis-induced hypotension for at least one hour despite adequate fluid resuscitation according to clinical judgement. Following the initial one hour on at least 0.1 µg/kg/min norepinephrine or equivalent, any dose of vasopressor counts as vasopressor therapy.
✓. Have AKI according to at least one of the below KDIGO criteria, a to d:
✓. An absolute increase in serum or plasma creatinine (CR) by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 hours.
✓. A relative increase in CR to ≥1.5 times the pre-AKI reference CR value which is known or presumed to have occurred within prior 7 days.
Exclusion criteria
What they're measuring
1
28-day All-cause Mortality: Main Trial Population
Timeframe: 28 days
2
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population
✕. a) At sites where enrolment of 'moderate' CKD patients is allowed, patients with 'severe' CKD defined as a pre-AKI reference eGFR \<25 mL/min/1.73 m2 are excluded.
✕. Advanced chronic liver disease, defined as a Child-Pugh score of 10 to 15 (Class C).
✕. Acute pancreatitis without proven infection.
✕. Urosepsis related to suspected or proven urinary tract obstruction.
✕. Main cause of AKI not sepsis.
✕. Proven or suspected SARS-CoV-2 infection. NOTE: This exclusion criterion does not apply to patients in the COVID-19 population, in which COVID-19 should be the main cause of SA-AKI.