(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 States, Australia, Austria676 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — does that mean the treatment was found to be unsafe or ineffective for sepsis-associated acute kidney injury, and how should that affect how I think about alkaline phosphatase as a potential option for me?
2Since the trial was measuring 28-day all-cause mortality as its main goal, what does that tell us about how serious my condition is and whether the risks of an experimental treatment like this would have been worth it at my stage?
3The trial had a separate group for people with moderate chronic kidney disease — does my kidney function history put me in a similar category, and does that change what treatment options my doctor would recommend for me?
4Given that this Phase 3 trial was terminated, are there other active or completed studies on alkaline phosphatase for sepsis-related kidney injury that my doctor thinks are worth looking at, or is standard care the most evidence-based path right now?
5Since this trial included a COVID-19 subgroup, does my specific situation — whether or not COVID-19 was involved in my sepsis — affect which treatments or trials my doctor would consider most appropriate for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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.