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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04411472
Registration number
NCT04411472
Ethics application status
Date submitted
28/05/2020
Date registered
2/06/2020
Date last updated
3/06/2024
Titles & IDs
Public title
(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
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Scientific 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
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Secondary ID [1]
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AP-recAP-AKI-03-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Kidney Injury Due to Sepsis
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Renal and Urogenital
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0
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Kidney disease
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Injuries and Accidents
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Recombinant human alkaline phosphatase
Other interventions - Placebo
Experimental: active - recombinant human alkaline phosphatase 1.6mg/kg 3 daily 1 hour infusions
Placebo Comparator: placebo - matching placebo
Other interventions: Recombinant human alkaline phosphatase
patients with SA-AKI are randomly assigned in a 1:1 ratio to either placebo or 1.6 mg/kg recAP.
Other interventions: Placebo
Placebo
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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28-day All-cause Mortality: Main Trial Population
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Assessment method [1]
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To demonstrate an effect of recAP on 28 day all cause mortality
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Timepoint [1]
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28 days
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Primary outcome [2]
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28-day All-cause Mortality: Moderate Chronic Kidney Disease Population
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Assessment method [2]
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To demonstrate an effect of recAP on 28 day all cause mortality
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Timepoint [2]
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28 days
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Primary outcome [3]
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28-day All-cause Mortality: COVID-19 Population
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Assessment method [3]
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To demonstrate an effect of recAP on 28 day all cause mortality
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Timepoint [3]
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28 days
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Secondary outcome [1]
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Major Adverse Kidney Events 90: Main Trial Population
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Assessment method [1]
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Major adverse kidney events (MAKE) 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or greater than or equal to 25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-acute kidney injury reference level.
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Timepoint [1]
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90 Days
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Secondary outcome [2]
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Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population
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Assessment method [2]
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Major adverse kidney events (MAKE) 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or greater than or equal to 25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-acute kidney injury reference level.
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Timepoint [2]
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90 Days
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Secondary outcome [3]
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Major Adverse Kidney Events 90: COVID-19 Population
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Assessment method [3]
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Major adverse kidney events (MAKE) 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or greater than or equal to 25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-acute kidney injury reference level.
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Timepoint [3]
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90 Days
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Secondary outcome [4]
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Major Adverse Kidney Events Through Day 90: Combined Population
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Assessment method [4]
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Major Adverse Kidney Events through day 90 (MAKE90A) :
death until day 90
greater than 25% drop in estimated glomerular filtration rate at Day 90
on renal replacement therapy (RRT) at day 90 OR on RRT through Day 28
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Timepoint [4]
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90 Days
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Secondary outcome [5]
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Days Alive and Free of Organ Support Through Day 28: Main Trial Population
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Assessment method [5]
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Days alive and free of organ support through Day 28, ie, days alive with no mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors, or inotropes (with death within 28 days counting as zero days)
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Timepoint [5]
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28 days
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Secondary outcome [6]
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Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population
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Assessment method [6]
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Days alive and free of organ support through Day 28, ie, days alive with no mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors, or inotropes (with death within 28 days counting as zero days)
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Timepoint [6]
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0
28 days
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Secondary outcome [7]
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0
Days Alive and Free of Organ Support Through Day 28: COVID-19 Population
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Assessment method [7]
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Days alive and free of organ support through Day 28, ie, days alive with no mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors, or inotropes (with death within 28 days counting as zero days)
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Timepoint [7]
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0
28 days
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Secondary outcome [8]
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Days Alive and Out of the ICU Through Day 28: Main Trial Population
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Assessment method [8]
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Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).
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Timepoint [8]
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28 days
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Secondary outcome [9]
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Days Alive and Out of the ICU Through Day 28: Moderate Chronic Kidney Disease Population
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Assessment method [9]
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Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).
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Timepoint [9]
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28 days
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Secondary outcome [10]
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Days Alive and Out of the ICU Through Day 28: COVID-19 Population
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Assessment method [10]
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Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).
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Timepoint [10]
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28 days
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Secondary outcome [11]
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90-day All Cause Mortality: Main Trial Population
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Assessment method [11]
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90-Day all-cause mortality
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Timepoint [11]
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90 days
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Secondary outcome [12]
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90-day All Cause Mortality: Moderate Chronic Kidney Disease Population
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Assessment method [12]
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90-Day all-cause mortality
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Timepoint [12]
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90 days
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Secondary outcome [13]
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90-day All Cause Mortality: COVID-19 Population
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Assessment method [13]
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90-Day all-cause mortality
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Timepoint [13]
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90 days
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Eligibility
Key inclusion criteria
1. 18 years or older.
2. In the ICU or intermediate care unit for clinical reasons.
3. Have sepsis requiring vasopressor (norepinephrine, epinephrine, dopamine,
phenylephrine, vasopressin, or angiotensin II) therapy, i.e.:
1. suspected or proven bacterial or viral infection. and
2. 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.
The combination of a) and b) automatically ensures that patients fulfill the Sepsis 3
criteria as 0.1 µg/kg/min norepinephrine corresponds to a score of +4 on the
Cardiovascular sub-score of the SOFA score.
4. Have AKI according to at least one of the below KDIGO criteria, a to d:
1. An absolute increase in serum or plasma creatinine (CR) by =0.3 mg/dL (=26.5
µmol/L) within 48 hours.
or
2. 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.
or
3. A decrease in urinary output to <0.5 mL/kg/hour for a minimum of 6 hours
following adequate fluid resuscitation.
or d) If the patient does not have a known history of CKD and there is no pre-AKI
reference CR value available from the past 12 months available from the past 12
months: a CR value greater or equal to the levels presented in Table 1, with the
increase in CR presumed to have occurred within prior 7 days.
5. Provision of signed and dated ICF in accordance with local regulations.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. 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.
- For patients with known CKD, the most recent eGFR prior to index hospitalization
needs to be documented as =25 mL/min/1.73 m2.
- For patients with known CKD but no known eGFR prior to hospitalization,
presentation eGFR between 25-60 mL/min/1.73 m2 can also be used to rule out
'severe' CKD.
b) At sites where enrolment of 'moderate' CKD patients is NOT allowed, patients
with 'moderate' and 'severe' CKD defined as a pre-AKI reference eGFR <45
mL/min/1.73 m2 are excluded.
- For patients with known CKD, the most recent eGFR prior to index hospitalization
needs to be documented as =45 mL/min/1.73 m2.
- For patients with known CKD but no known eGFR prior to hospitalization,
presentation eGFR between 45-60 mL/min/1.73 m2 can also be used to rule out
'moderate' and 'severe' CKD.
2. Advanced chronic liver disease, defined as a Child-Pugh score of 10 to 15 (Class C).
3. Acute pancreatitis without proven infection.
4. Urosepsis related to suspected or proven urinary tract obstruction.
5. Main cause of AKI not sepsis.
6. 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.
7. Severe burns requiring ICU treatment.
8. Severely immunosuppressed, e.g. due to:
- hematopoietic cell transplantation within past 6 months prior to Screening or
acute or chronic graft-versus-host disease
- solid organ transplantation
- leukopenia not related to sepsis, i.e., preceding sepsis
- Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)
- receiving chemotherapy within 30 days prior to Screening.
9. At high risk of being LTFU, e.g., due to known current or recent (within the last 6
months) IV drug abuse or known to be homeless.
10. Limitations to use of mechanical ventilation (MV), RRT or vasopressors and inotropes
(NOTE: limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion
criterion).
11. Previous administration of recAP.
12. Use of a non-marketed drug within the last month or concurrent or planned
participation in a clinical trial for a non-marketed drug or device. (NOTE:
Co-enrollment or concurrent participation in observational, non-interventional trials
using no protocolized treatments or procedures are always allowed. Co-enrollment or
concurrent participation in trials using protocolized treatments or procedures, e.g.
blood draws, requires pre-approval by the TSC).
13. Current or planned extracorporeal membrane oxygenation (ECMO).
14. On RRT >24 hours before start of trial drug.
15. No longer on vasopressor therapy at time of randomization.
16. On continuous vasopressor therapy for >72 hours before start of trial drug.
17. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 based on the most
recent available CR sample at time of screening (NOTE: will often be the sample used
to diagnose AKI). eGFR should be calculated using the Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) formula. In Japan, the CKD-EPI formula with
Japanese coefficient should be used. If local regulations prohibit correcting for race
in the calculation of eGFR, it is acceptable to use the formula without correcting for
race.
18. Not feasible to start trial drug within:
1. 48 hours from AKI diagnosis, when AKI diagnosis precedes start of vasopressor
therapy.
or
2. 24 hours from AKI diagnosis, when AKI is diagnosed after start of vasopressor
therapy.
19. Pregnant or nursing women.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/08/2022
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Sample size
Target
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Accrual to date
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Final
676
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Bendigo Hospital - Bendigo
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Recruitment hospital [3]
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Footscray Hospital - Footscray
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Recruitment hospital [4]
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Austin Hospital - Melbourne
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Recruitment hospital [5]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [6]
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Sunshine Hospital ICU - Western Hospital - Saint Albans
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Recruitment hospital [7]
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Gold Coast University Hospital (GCUH) - Southport
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3550 - Bendigo
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Recruitment postcode(s) [3]
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3011 - Footscray
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Recruitment postcode(s) [4]
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3084 - Melbourne
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Recruitment postcode(s) [5]
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2305 - New Lambton Heights
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Recruitment postcode(s) [6]
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3021 - Saint Albans
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Recruitment postcode(s) [7]
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4215 - Southport
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Georgia
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Illinois
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Minnesota
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Wisconsin
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Austria
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Graz
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Austria
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Innsbruck
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Charleroi
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Genk
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Gent
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Woluwe-Saint-Lambert
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Aalborg
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Plymouth
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Funding & Sponsors
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Commercial sector/Industry
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AM-Pharma
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04411472
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A Legters
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AM-Pharma
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04411472
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