Trial · NCT04411472

(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI

NCT04411472, Phase 3, Terminated, AM-Pharma; results first posted 2024-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI. Trials, record NCT04411472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04411472

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
NCT number: NCT04411472
Status: Terminated
Phases: Phase 3
Enrollment: 676 participants, actual
Lead sponsor: AM-Pharma
Conditions: Acute Kidney Injury Due to Sepsis
Interventions: Recombinant human alkaline phosphatase, Placebo
First posted: 2020-06-02
Last updated: 2026-11-09
Results first posted: 2024-06-03
Limitations and caveats: The trial was terminated early due to futility being reached for the primary endpoint of all cause mortality at day 28 at the interim analysis.

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	28-day All-cause Mortality: Main Trial Population	28 days	To demonstrate an effect of recAP on 28 day all cause mortality
Primary	28-day All-cause Mortality: Moderate Chronic Kidney Disease Population	28 days	To demonstrate an effect of recAP on 28 day all cause mortality
Primary	28-day All-cause Mortality: COVID-19 Population	28 days	To demonstrate an effect of recAP on 28 day all cause mortality
Secondary	Major Adverse Kidney Events 90: Main Trial Population	90 Days	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.
Secondary	Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population	90 Days	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.
Secondary	Major Adverse Kidney Events 90: COVID-19 Population	90 Days	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.
Secondary	Major Adverse Kidney Events Through Day 90: Combined Population	90 Days	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
Secondary	Days Alive and Free of Organ Support Through Day 28: Main Trial Population	28 days	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)
Secondary	Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population	28 days	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)
Secondary	Days Alive and Free of Organ Support Through Day 28: COVID-19 Population	28 days	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)

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	28-day All-cause Mortality: Main Trial Population	28 days	Main Trial modified intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	28-day All-cause Mortality: Moderate Chronic Kidney Disease Population	28 days	Moderate Chronic Kidney Disease modified intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	28-day All-cause Mortality: COVID-19 Population	28 days	COVID-19 modified intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Major Adverse Kidney Events 90: Main Trial Population	90 Days	Main Trial modified intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population	90 Days	Moderate Chronic Kidney Disease modified intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Major Adverse Kidney Events 90: COVID-19 Population	90 Days	COVID-19 modified intent-to-treat Population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Major Adverse Kidney Events Through Day 90: Combined Population	90 Days	Combined population: From the 650 patients in the mITT population (321 Placebo and 329 recAP), 649 were analysed in the combined population (1 participant randomized and treated with placebo has been excluded as no efficacy data were available). In the combined population participants were analyzed as treated, resulting in 319 Placebo and 330 recAP participants (2 participants randomized to Placebo were treated with recAP, 1 participant randomized to recAP was treated with placebo).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days Alive and Free of Organ Support Through Day 28: Main Trial Population	28 days	Main Trial modified intent-to-treat Population	days	MEAN
SECONDARY	Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population	28 days	Moderate Chronic Kidney Disease modified intent-to-treat Population	days	MEAN
SECONDARY	Days Alive and Free of Organ Support Through Day 28: COVID-19 Population	28 days	COVID-19 modified intent-to-treat Population	days	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group100

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
28-day All-cause Mortality: Main Trial Population	Placebo	Participants with known survival status at Day 28	272	Participants
28-day All-cause Mortality: Main Trial Population	recAP 1.6 mg/kg	Participants with known survival status at Day 28	279	Participants
28-day All-cause Mortality: Main Trial Population	Placebo	Number of participants died by Day 28	69	Participants
28-day All-cause Mortality: Main Trial Population	recAP 1.6 mg/kg	Number of participants died by Day 28	80	Participants
28-day All-cause Mortality: Main Trial Population	Placebo	Participants where survival status is unknown at Day 28	5	Participants
28-day All-cause Mortality: Main Trial Population	recAP 1.6 mg/kg	Participants where survival status is unknown at Day 28	0	Participants
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population	Placebo	Participants with known survival status at Day 28	31	Participants
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population	recAP 1.6 mg/kg	Participants with known survival status at Day 28	29	Participants
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population	Placebo	Number of participants died by Day 28	10	Participants
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population	recAP 1.6 mg/kg	Number of participants died by Day 28	6	Participants

1 to 10 of 100Source ClinicalTrials.gov

See all 100 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo (Main Trial Population)	277
Overall Study	STARTED	recAP 1.6 mg/kg (Main Trial Population)	279
Overall Study	STARTED	Placebo (Moderate CKD Population)	31
Overall Study	STARTED	recAP 1.6 mg/kg (Moderate CKD Population)	30
Overall Study	STARTED	Placebo (COVID-19 Population)	13
Overall Study	STARTED	recAP 1.6 mg/kg (COVID-19 Population)	20
Overall Study	COMPLETED	Placebo (Main Trial Population)	253
Overall Study	COMPLETED	recAP 1.6 mg/kg (Main Trial Population)	248
Overall Study	COMPLETED	Placebo (Moderate CKD Population)	27
Overall Study	COMPLETED	recAP 1.6 mg/kg (Moderate CKD Population)	29

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events1,530

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypokalaemia	Metabolism and nutrition disorders	Placebo (Main Trial Safety Population, n=276)	12	276	13
other	Hypokalaemia	Metabolism and nutrition disorders	recAP 1.6 mg/kg (Main Trial Safety Population, n=280)	15	280	15
other	Hypokalaemia	Metabolism and nutrition disorders	Placebo (Moderate CKD Trial Safety Population, n=31)	1	31	1
other	Hypokalaemia	Metabolism and nutrition disorders	recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30)	0	30	0
other	Hypokalaemia	Metabolism and nutrition disorders	Placebo (Covid-19 Safety Population, n=13)	0	13	0
other	Hypokalaemia	Metabolism and nutrition disorders	recAP 1.6 mg/kg (Covid-19 Safety Population, n=20)	1	20	1
other	Hypernatraemia	Metabolism and nutrition disorders	Placebo (Main Trial Safety Population, n=276)	9	276	9
other	Hypernatraemia	Metabolism and nutrition disorders	recAP 1.6 mg/kg (Main Trial Safety Population, n=280)	11	280	11
other	Hypernatraemia	Metabolism and nutrition disorders	Placebo (Moderate CKD Trial Safety Population, n=31)	0	31	0
other	Hypernatraemia	Metabolism and nutrition disorders	recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30)	0	30	0

1 to 10 of 1,530Source ClinicalTrials.gov

See all 1,530 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo (Main Trial Safety Population, n=276)	92	276
Total, all-cause mortality	recAP 1.6 mg/kg (Main Trial Safety Population, n=280)	108	280
Total, all-cause mortality	Placebo (Moderate CKD Trial Safety Population, n=31)	14	31
Total, all-cause mortality	recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30)	7	30
Total, all-cause mortality	Placebo (Covid-19 Safety Population, n=13)	11	13
Total, all-cause mortality	recAP 1.6 mg/kg (Covid-19 Safety Population, n=20)	7	20
Total, other adverse events	Placebo (Main Trial Safety Population, n=276)	142	276
Total, other adverse events	recAP 1.6 mg/kg (Main Trial Safety Population, n=280)	131	280
Total, other adverse events	Placebo (Moderate CKD Trial Safety Population, n=31)	18	31
Total, other adverse events	recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30)	13	30

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37012016	RESULT	PubMed
38172296	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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