AzTrials
AzTrials

Acute Kidney Injury Due to SepsisPhase 3NCT04411472

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

A Phase 3 study testing Recombinant human alkaline phosphatase in people with Acute Kidney Injury Due to Sepsis, run by AM-Pharma at 122 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Kidney Injury Due to Sepsis
What is being tested?
Recombinant human alkaline phosphatase
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
676 participants
Where
122 sitesin 15 countries
Study dates
2 Nov 2020to 18 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
Show all 14Show fewer
  • 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.
  • or
  • 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
  • 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.
  • Provision of signed and dated ICF in accordance with local regulations.

Who cannot join

  • 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.
  • 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.
Show all 32Show fewer
  • 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.
  • Severe burns requiring ICU treatment.
  • 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.
  • 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.
  • Limitations to use of mechanical ventilation (MV), RRT or vasopressors and inotropes (NOTE: limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion criterion).
  • Previous administration of recAP.
  • 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).
  • Current or planned extracorporeal membrane oxygenation (ECMO).
  • On RRT >24 hours before start of trial drug.
  • No longer on vasopressor therapy at time of randomization.
  • On continuous vasopressor therapy for >72 hours before start of trial drug.
  • 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.
  • Not feasible to start trial drug within:
  • 48 hours from AKI diagnosis, when AKI diagnosis precedes start of vasopressor therapy.
  • or
  • 24 hours from AKI diagnosis, when AKI is diagnosed after start of vasopressor therapy.
  • Pregnant or nursing women.

Trial locations and contacts

122 sites in 15 countries.

122 sites in 15 countries

United States16 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87131

  • Emory Clinical Cardiovascular Research Institute

    Atlanta, Georgia, 30322-1007

  • University of Virginia Health System

    Charlottesville, Virginia, 22908-0817

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219

  • The Ohio State University - Dorothy M. Davis Heart and Lung Research Institute

    Columbus, Ohio, 43210

  • 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

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095-8358

  • Froedtert & the Medical College of Wisconsin Froedtert Hospital

    Milwaukee, Wisconsin, 53226-3522

  • UPMC CancerCenter at Magee - Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3108

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213-3108

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724-5057

  • The George Washington University Medical Faculty Associates - Anesthesiology

    Washington D.C., District of Columbia, 20037-2342

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

France16 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • Centre Hospitalier d'Argenteuil

    Argenteuil, 95107

  • Centre Hospitalier de Bethune Germon et Gauthier

    Béthune, 62408

  • Centre Hospitalier René-Dubos

    Cergy-Pontoise, 95303

  • CHU Dijon - Hôpital François Mitterrand

    Dijon, 21079

  • Centre Hospitalier Départemental de Vendée - Les Oudairies

    La Roche-sur-Yon, 85000

  • Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270

  • Centre Hospitalier du Mans

    Le Mans, 72000

  • CHU Limoges - Hôpital Dupuytren

    Limoges, 87000

  • CHU de Nancy

    Nancy, 54000

  • CHU de Nantes - Hôtel-Dieu

    Nantes, 44000

  • CHU de Nimes - Hopital Universitaire Caremeau

    Nîmes, 30029

  • Hôpital La Source

    Orléans, 45067

  • Hôpital Lariboisière

    Paris, 75010

  • Hôpitaux Universitaires de Strasbourg - Hôpital Civil

    Strasbourg, 67091

  • CHRU de Tours - Hôpital Bretonneau

    Tours, 37044

Other trials in France

Japan11 sites

  • Tokyo Medical University Hachioji Medical Center

    Hachioji-Shi, 193-0998

  • Hiroshima University Hospital

    Hiroshima

  • Aso Iizuka Hospital

    Izuka-shi, 820-8505

  • Rinku General Medical Center

    Izumisano, 598-8577

  • Nara Medical University Hospital

    Kashihara-shi, 634-8522

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Omihachiman Community Medical Center

    Ōmihachiman, 523-0082

  • Osaka City General Hospital

    Osaka, 534-0021

  • Osaka Police Hospital

    Osaka, 543-0035

  • Fujita Health University Hospital

    Toyoake-Shi, 470-1192

  • National Hospital Organization - Yokohama Medical Center

    Yokohama, 245-8575

Other trials in Japan

Canada10 sites

  • Peter Lougheed Centre

    Calgary, T1Y 6J4

  • Foothills Medical Centre

    Calgary, T2N 2T9

  • Rockyview General Hospital

    Calgary, T2V 1P9

  • Alberta Health Services - South Health Campus Hospital

    Calgary, T3M 1M4

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

  • The Ottawa Hospital - Civic Campus

    Ottawa, K1Y 4E9

  • Hôpital de l'Enfant-Jésus

    Québec, G1J 1Z4

  • St. Paul's Hospital

    Vancouver, V6Z 1Y6

  • Royal Jubilee Hospital (RJH)

    Victoria, V8R 1J8

  • Victoria General Hospital (VGH)

    Victoria, V8R 1J8

Other trials in Canada

Denmark10 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus N, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Herning Regional Hospital

    Herning, 7400

  • Nordsjællands Hospital

    Hillerød, 3400

  • Sjaellands Universitetshospital, Koge - Kardiologisk Afdeling

    Køge, 4600

  • Odense Universitetshospital

    Odense C, 5000

  • Regionshospitalet Randers

    Randers, 8930

  • Slagelse Sygehus

    Slagelse, 4200

  • Hospitalsenhed Midt

    Viborg, 8800

Other trials in Denmark

Belgium9 sites

  • Centre Hospitalier Universitaire Brugmann

    Brussels, 1020

  • Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie

    Charleroi, 6042

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Brussel

    Jette, 1090

  • Hôpital de JOLIMONT

    La Louvière, 7100

  • Clinique Saint-Pierre- Ottignies

    Ottignies, 1340

  • Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200

  • CHU UCL Namur - Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

New Zealand8 sites

  • Auckland City Hospital

    Auckland, 1023

  • Middlemore Clinical Trials

    Auckland, 2025

  • Christchurch Hospital

    Christchurch, 8140

  • Dunedin Hospital

    Dunedin, 9016

  • Auckland City Hospital

    Grafton, 1023

  • Hawke's Bay Hospital Soldiers' Memorial

    Hastings, 4172

  • Lakes District Health Board - Rotorua Hospital

    Rotorua, 3046

  • Wellington Hospital

    Wellington, WGN, 6021

Other trials in New Zealand

Spain8 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 8916

  • Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 8035

  • Hospital Universitari de Bellvitge (IDIBELL)

    Barcelona, 8907

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17007

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Parc Taulí Sabadell Hospital Universitari

    Sabadell, 8208

  • Universitat de Barcelona - Hospital Universitari Mutua Terrassa (HUMT)

    Terrassa, 8221

Other trials in Spain

Australia7 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Bendigo Hospital

    Bendigo, 3550

  • Footscray Hospital

    Footscray, 3011

  • Austin Hospital

    Melbourne, 3084

  • John Hunter Hospital

    New Lambton Heights, 2305

  • Sunshine Hospital ICU - Western Hospital

    Saint Albans, 3021

  • Gold Coast University Hospital (GCUH)

    Southport, 4215

Other trials in Australia

Netherlands7 sites

  • Jeroen Bosch Ziekenhuis lokatie GZG

    's-Hertogenbosch, North Brabant, 5223 GZ

  • Amsterdam UMC - VUMC

    Amsterdam, 1081 HV

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Medisch Spectrum Twente

    Enschede, KZ 7512

  • Zuyderland Medisch Centrum, Heerlen

    Heerlen, Heerlen

  • Radboud UMC

    Nijmegen, 6500 HB

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ

Other trials in Netherlands

Germany5 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Universitätsklinikum Hamburg-Eppendorf (UKE)

    Hamburg, 20246

  • University Hospital Jena - Klinik fur Neurologie

    Jena, 7747

  • Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Gastroenterologie und Rheumatologie

    Leipzig, 4103

  • University Hospital Münster

    Münster, 48149

Other trials in Germany

United Kingdom5 sites

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, LND, NW1 2BU

  • Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

    London, SE1 7EH

  • Plymouth Hospitals NHS Trust - Derriford Hospital

    Plymouth, PL6 8DH

Other trials in United Kingdom

Ireland4 sites

  • St. James's Hospital

    Dublin, D08 NHY1

  • Tallaght University Hospital

    Dublin, D24NR0A

  • St. Vincent's University Hospital

    Dublin, Dublin 4

  • National University of Ireland, Galway

    Galway, G, H91 YR71

Other trials in Ireland

Austria3 sites

  • Medizinische Universitaet Graz - Klinik fuer Innere Medizin

    Graz, 8036

  • Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin I

    Innsbruck, 6020

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

Finland3 sites

  • Helsinki University Central Hospital (HUCH)

    Helsinki, 290

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Hospital (TYKS)

    Turku, 20521

Other trials in Finland

About this study

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

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:

Read more
  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.

Read the detailed description

Sepsis is the leading cause of acute kidney injury (AKI) and a major cause of death. Patients with SA-AKI have a high mortality and morbidity and are at risk of developing chronic kidney disease. AP is a homodimeric endogenous enzyme present in many cells and organs, e.g., intestines, placenta, liver, bone, kidney, and granulocytes. It exerts detoxifying effects through dephosphorylation of endotoxins; pathogen associated molecular pattern molecules (PAMPS e.g., lipopolysaccharide) and damage-associated molecular pattern molecules (DAMPS e.g., adenosine tri- and di-phosphate). In animal models of sepsis and AKI, administration of AP attenuates the inflammatory response, improves renal function and/or reduces mortality.

AM-Pharma B.V. is developing AP as a novel, recombinant chimeric human AP medicinal product, called recAP, to be used as an intravenous infusion for the treatment of SA-AKI. In the Phase 2 trial STOP-AKI, a survival benefit was observed in the two highest dose groups, 0.8 mg/kg and 1.6 mg/kg groups, compared to the placebo group. There were no safety or tolerability concerns for any of the doses tested (0.4, 0.8 and 1.6 mg/kg). The 1.6 mg/kg recAP dose was selected for this Phase 3 trial based on the significant survival benefit observed. PK/PD simulations also confirmed this dose to have the most pronounced treatment effect.

The primary objective of this Phase 3 trial is to confirm the mortality benefit seen in STOP-AKI by demonstrating a reduction in 28 day all cause mortality in patients with SA-AKI treated with 1.6 mg/kg recAP.

Being tested
Recombinant human alkaline phosphatase, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant human alkaline phosphataseBiological

    Also called ilofotase alfa

    patients with SA-AKI are randomly assigned in a 1:1 ratio to either placebo or 1.6 mg/kg recAP.

  • PlaceboOther

    Placebo

Study groups in NCT04411472
Study groupRoleWhat they receive
activeExperimentalrecombinant human alkaline phosphatase 1.6mg/kg 3 daily 1 hour infusions
Receives: Biological: Recombinant human alkaline phosphatase
placeboPlacebo comparatormatching placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day All-cause Mortality: Main Trial Population

    To demonstrate an effect of recAP on 28 day all cause mortality

    Measured: 28 days

  2. 28-day All-cause Mortality: Moderate Chronic Kidney Disease Population

    To demonstrate an effect of recAP on 28 day all cause mortality

    Measured: 28 days

  3. 28-day All-cause Mortality: COVID-19 Population

    To demonstrate an effect of recAP on 28 day all cause mortality

    Measured: 28 days

Secondary outcomes (13)

  1. Major Adverse Kidney Events 90: Main Trial Population

    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.

    Measured: 90 Days

  2. Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population

    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.

    Measured: 90 Days

  3. Major Adverse Kidney Events 90: COVID-19 Population

    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.

    Measured: 90 Days

  4. Major Adverse Kidney Events Through Day 90: Combined Population

    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

    Measured: 90 Days

  5. Days Alive and Free of Organ Support Through Day 28: Main Trial Population

    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)

    Measured: 28 days

  6. Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population

    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)

    Measured: 28 days

  7. Days Alive and Free of Organ Support Through Day 28: COVID-19 Population

    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)

    Measured: 28 days

  8. Days Alive and Out of the ICU Through Day 28: Main Trial Population

    Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

    Measured: 28 days

  9. Days Alive and Out of the ICU Through Day 28: Moderate Chronic Kidney Disease Population

    Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

    Measured: 28 days

  10. Days Alive and Out of the ICU Through Day 28: COVID-19 Population

    Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

    Measured: 28 days

  11. 90-day All Cause Mortality: Main Trial Population

    90-Day all-cause mortality

    Measured: 90 days

  12. 90-day All Cause Mortality: Moderate Chronic Kidney Disease Population

    90-Day all-cause mortality

    Measured: 90 days

  13. 90-day All Cause Mortality: COVID-19 Population

    90-Day all-cause mortality

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start2 Nov 2020
  3. Primary completion18 Aug 2022
  4. Study completion18 Aug 2022

Why it stopped: The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04411472
Sponsor's protocol ID
AP-recAP-AKI-03-01
Status last verified
May 2024
First submitted
28 May 2020
Last updated
3 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Pickkers P, Angus DC, Bass K, Bellomo R, van den Berg E, Bernholz J, Bestle MH, Doi K, Doig CJ, Ferrer R, Francois B, Gammelager H, Pedersen UG, Hoste E, Iversen S, Joannidis M, Kellum JA, Liu K, Meersch M, Mehta R, Millington S, Murray PT, Nichol A, Ostermann M, Pettila V, Solling C, Winkel M, Young PJ, Zarbock A; REVIVAL investigators. Phase-3 trial of recombinant human alkaline phosphatase for patients with sepsis-associated acute kidney injury (REVIVAL). Intensive Care Med. 2024 Jan;50(1):68-78. doi: 10.1007/s00134-023-07271-w. Epub 2024 Jan 3.

    PubMed 38172296

  • Pickkers P, Angus DC, Arend J, Bellomo R, van den Berg E, Bernholz J, Bestle M, Broglio K, Carlsen J, Doig CJ, Ferrer R, Joannidis M, Francois B, Doi K, Kellum JA, Laterre PF, Liu K, Mehta RL, Murray PT, Ostermann M, Pettila V, Richards S, Young P, Zarbock A, Kjolbye AL. Study protocol of a randomised, double-blind, placebo-controlled, two-arm parallel-group, multi-centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with sepsis-associated acute kidney injury. BMJ Open. 2023 Apr 3;13(4):e065613. doi: 10.1136/bmjopen-2022-065613.

    PubMed 37012016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant human alkaline phosphatase in people with Acute Kidney Injury Due to Sepsis, run by AM-Pharma at 122 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, France, Japan, Canada, Denmark and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day All-cause Mortality: Main Trial Population (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04411472, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in