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

PHASE3TerminatedINTERVENTIONAL
Enrollment

676

Participants

Timeline

Start Date

November 2, 2020

Primary Completion Date

August 18, 2022

Study Completion Date

August 18, 2022

Conditions
Acute Kidney Injury Due to Sepsis
Interventions
BIOLOGICAL

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

Placebo

Placebo

Trial Locations (122)

290

Helsinki University Central Hospital (HUCH), Helsinki

1020

Centre Hospitalier Universitaire Brugmann, Brussels

1023

Auckland City Hospital, Auckland

Auckland City Hospital, Grafton

1090

Universitair Ziekenhuis Brussel, Jette

1200

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

1340

Clinique Saint-Pierre- Ottignies, Ottignies

2025

Middlemore Clinical Trials, Auckland

2100

Rigshospitalet, Copenhagen

2305

John Hunter Hospital, New Lambton Heights

3011

Footscray Hospital, Footscray

3021

Sunshine Hospital ICU - Western Hospital, Saint Albans

3046

Lakes District Health Board - Rotorua Hospital, Rotorua

3084

Austin Hospital, Melbourne

3400

Nordsjællands Hospital, Hillerød

3550

Bendigo Hospital, Bendigo

3600

Ziekenhuis Oost-Limburg, Genk

4103

Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Gastroenterologie und Rheumatologie, Leipzig

4172

Hawke's Bay Hospital Soldiers' Memorial, Hastings

4200

Slagelse Sygehus, Slagelse

4215

Gold Coast University Hospital (GCUH), Southport

4600

Sjaellands Universitetshospital, Koge - Kardiologisk Afdeling, Køge

5000

Odense Universitetshospital, Odense C

5042

Flinders Medical Centre, Bedford Park

5530

CHU UCL Namur - Mont-Godinne, Yvoir

6020

Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin I, Innsbruck

Medizinische Universität Innsbruck, Innsbruck

6021

Wellington Hospital, Wellington

6042

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

7100

Hôpital de JOLIMONT, La Louvière

7400

Herning Regional Hospital, Herning

7747

University Hospital Jena - Klinik fur Neurologie, Jena

8003

Hospital del Mar, Barcelona

8035

Hospital Universitario Vall d'Hebron, Barcelona

8036

Medizinische Universitaet Graz - Klinik fuer Innere Medizin, Graz

8140

Christchurch Hospital, Christchurch

8200

Aarhus University Hospital, Aarhus N

8208

Parc Taulí Sabadell Hospital Universitari, Sabadell

8221

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

8800

Hospitalsenhed Midt, Viborg

8907

Hospital Universitari de Bellvitge (IDIBELL), Barcelona

8916

Hospital Universitari Germans Trias i Pujol, Badalona

8930

Regionshospitalet Randers, Randers

9000

Universitair Ziekenhuis Gent, Ghent

Aalborg Universitetshospital, Aalborg

9016

Dunedin Hospital, Dunedin

17007

Hospital Universitari de Girona Doctor Josep Trueta, Girona

20246

Universitätsklinikum Hamburg-Eppendorf (UKE), Hamburg

20521

Turku University Hospital (TYKS), Turku

21079

CHU Dijon - Hôpital François Mitterrand, Dijon

27157

Wake Forest Baptist Medical Center, Winston-Salem

28040

Hospital Clínico San Carlos, Madrid

30029

CHU de Nimes - Hopital Universitaire Caremeau, Nîmes

33521

Tampere University Hospital, Tampere

37044

CHRU de Tours - Hôpital Bretonneau, Tours

43210

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

44000

CHU de Nantes - Hôtel-Dieu, Nantes

45067

Hôpital La Source, Orléans

45219

University of Cincinnati Cancer Institute, Cincinnati

48149

University Hospital Münster, Münster

49933

Centre Hospitalier Universitaire d'Angers, Angers

52074

Universitätsklinikum Aachen, Aachen

54000

CHU de Nancy, Nancy

55101

Regions Hospital, Saint Paul

60035

NorthShore Medical Group - Bannockburn, Highland Park

62408

Centre Hospitalier de Bethune Germon et Gauthier, Béthune

67091

Hôpitaux Universitaires de Strasbourg - Hôpital Civil, Strasbourg

72000

Centre Hospitalier du Mans, Le Mans

75010

Hôpital Lariboisière, Paris

85000

Centre Hospitalier Départemental de Vendée - Les Oudairies, La Roche-sur-Yon

87000

CHU Limoges - Hôpital Dupuytren, Limoges

87131

University of New Mexico School of Medicine, Albuquerque

94270

Hôpital Bicêtre, Le Kremlin-Bicêtre

95107

Centre Hospitalier d'Argenteuil, Argenteuil

95303

Centre Hospitalier René-Dubos, Cergy-Pontoise

85724-5057

The University of Arizona Cancer Center, Tucson

90095-8358

Ronald Reagan UCLA Medical Center, Los Angeles

20037-2342

The George Washington University Medical Faculty Associates - Anesthesiology, Washington D.C.

30322-1007

Emory Clinical Cardiovascular Research Institute, Atlanta

60026-1301

Glenbrook Hospital, Glenview

40508-3215

University of Kentucky College of Medicine (UKCM), Lexington

15213-3108

UPMC CancerCenter at Magee - Womens Hospital, Pittsburgh

UPMC Presbyterian, Pittsburgh

22908-0817

University of Virginia Health System, Charlottesville

53226-3522

Froedtert & the Medical College of Wisconsin Froedtert Hospital, Milwaukee

T1Y 6J4

Peter Lougheed Centre, Calgary

T2N 2T9

Foothills Medical Centre, Calgary

T2V 1P9

Rockyview General Hospital, Calgary

T3M 1M4

Alberta Health Services - South Health Campus Hospital, Calgary

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

K1Y 4E9

The Ottawa Hospital - Civic Campus, Ottawa

G1J 1Z4

Hôpital de l'Enfant-Jésus, Québec

V6Z 1Y6

St. Paul's Hospital, Vancouver

V8R 1J8

Royal Jubilee Hospital (RJH), Victoria

Victoria General Hospital (VGH), Victoria

H91 YR71

National University of Ireland, Galway, Galway

D08 NHY1

St. James's Hospital, Dublin

D24NR0A

Tallaght University Hospital, Dublin

Dublin 4

St. Vincent's University Hospital, Dublin

193-0998

Tokyo Medical University Hachioji Medical Center, Hachioji-Shi

Unknown

Hiroshima University Hospital, Hiroshima

820-8505

Aso Iizuka Hospital, Izuka-shi

598-8577

Rinku General Medical Center, Izumisano

634-8522

Nara Medical University Hospital, Kashihara-shi

860-0008

National Hospital Organization Kumamoto Medical Center, Kumamoto

534-0021

Osaka City General Hospital, Osaka

543-0035

Osaka Police Hospital, Osaka

523-0082

Omihachiman Community Medical Center, Ōmihachiman

470-1192

Fujita Health University Hospital, Toyoake-Shi

245-8575

National Hospital Organization - Yokohama Medical Center, Yokohama

5223 GZ

Jeroen Bosch Ziekenhuis lokatie GZG, 's-Hertogenbosch

1081 HV

Amsterdam UMC - VUMC, Amsterdam

6716 RP

Ziekenhuis Gelderse Vallei, Ede

KZ 7512

Medisch Spectrum Twente, Enschede

Heerlen

Zuyderland Medisch Centrum, Heerlen, Heerlen

6500 HB

Radboud UMC, Nijmegen

6532 SZ

Canisius-Wilhelmina Ziekenhuis, Nijmegen

NW1 2BU

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

CF14 4XW

University Hospital of Wales, Cardiff

L7 8XP

Royal Liverpool University Hospital, Liverpool

SE1 7EH

Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital, London

PL6 8DH

Plymouth Hospitals NHS Trust - Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AM-Pharma

INDUSTRY