Back to resultsA Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (STOP-AKI)
Primary Purpose
Acute Kidney Injury
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
recAP
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring SA-AKI, Sepsis, AKI, Recombinant Alkaline Phosphatase, recAP
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent Form (patient, legal representative or independent investigator)
- Age 18 to 85 years, inclusive
- Is admitted to the ICU or Intermediate Care Unit
Has diagnosis of sepsis (< 96 hrs prior to first study drug), according to criteria defined by the American College of Chest Physicians/Society of Critical Care Medicine:
- Has a proven or strongly suspected bacterial infection.
- Has at least 2 of 4 SIRS criteria 72 hrs < screening and 96 hrs < first study drug
First diagnosis of AKI: AKI Stage 1 or greater, according to the AKIN criteria (time-window adjusted):
- Increase in serum creatinine > 26.2 µmol/L (0.30 mg/dL) in 48 hrs prior to screening, or
- Increase in serum creatinine to > 150% (> 1.5-fold) from reference creatinine value in 48 hrs prior to screening
- Urinary output < 0.5 mL/kg/h for > 6 hours following adequate fluid resuscitation
- Continuing AKI needs to be confirmed by a confirmative fluid corrected serum creatinine measure, or
- When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output < 0.5 mL/kg/h for > 6 hours), the oliguria or anuria should still meet the AKIN urine output criteria prior to randomization.
Exclusion Criteria:
- Woman of childbearing potential with a positive pregnancy test, pregnant, or breastfeeding.
- Weighs more than 115 kg (253 lb).
- Has life support limitations.
- Is known to be human immunodeficiency virus positive.
- Has urosepsis.
- Is already on dialysis (RRT) or anticipated to receive RRT within 24 hours after study drug dosing due to the underlying disease.
- Is receiving immunosuppressant treatment or is on chronic high doses of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg) can be included.
- Is expected to have rapidly fatal outcome (within 24 hours).
- Has known, confirmed fungal sepsis.
- Has advanced chronic liver disease, confirmed by a Child-Pugh score of 10 to 15.
- Has acute pancreatitis with no established source of infection.
- Has participated in another investigational study within 30 days prior to enrollment.
- Is not expected to survive for 28 days due to medical conditions other than SA AKI, including cancer, end-stage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 30 days, end stage lung disease, and end stage liver disease.
- Has known prior history of Chronic Kidney Disease with a documented estimated Glomerular Filtration Rate (eGFR) < 60 mL/min by Modification of Diet in Renal Disease MDRD or CKD-EPI formula, known GFR < 60 mL/min, or a known history of persistent creatinine level > 150 µmol/L (1.70 mg/dL) for reasons other than the current sepsis condition.
- Has diagnosis of malaria or other parasite infections.
- Has burns on > 20% of body surface.
- Has had AKI diagnosis according to inclusion criteria > 24 hours prior to study drug administration.
- Is anticipated to be treated with non-continuous RRT from Day 1 to Day 7.
- During Day 1 to Day 7 continuous RRT is anticipated to be started or stopped not according to per protocol criteria.
- The AKI is most likely attributable to other causes than sepsis, such as nephrotoxic drugs and renal perfusion-related.
- Improvement in serum creatinine of at least 0.30 mg/dL or (26.2 µmol/L) prior to administration of the study drug.
- Patients who use nephrotoxic medication and who fulfill the SA-AKI inclusion criteria at screening are not eligible if the use of this nephrotoxic medication is to continue when alternative, medically appropriate, non-nephrotoxic medication is available.
- Has a history of known IV drug abuse.
- Is an employee or family member of the investigator or study site personnel.
- Has active hematological malignancy.
Sites / Locations
- University of Alabama at Birmingham
- Tampa General Hospital, Division Emergency Medicine
- Eastern Idaho Medical Consultants LLC
- University of Cincinnati Medical Center
- UPMC
- University of Texas Houston Medical School
- Medizinische Universität Innsbruck
- Universitätsklinik für Allgemeine und Chirurgische Intensivmedizin
- Hôpital Erasme
- CHU UCL Mont Godinne
- University Hospital Ghent
- University Hospital Antwerpen
- Cliniques Universitaires Saint Luc-UCL
- CHU Brugmann
- UZ Brussel
- Fakultni nemocnice u sv. Anny v Brne
- Oblastni nemocnice Kolin, a.s.
- Fakultni nemocnice Plzen
- Helsingin Yliopistollinen Keskussairaala
- Kuopion Yliopistollinen Sairaala
- Tampereen yliopistollinen sairaala
- Hôpital Universitaire Dupuytren
- Hôpital Charles Nicolle
- Centre Hospitalier Departemental de Vendee
- CHU Angers
- Centre Hospitalier Victor Dupouy - hopital
- CHRU Nantes - Hospital
- Hôpital Lariboisière
- Hôpitaux Universitaires de Strasbourg
- University Hospital Frankfurt, Anaesthesia, Intensive Care Medicine & Pain Therapy
- Universitätsmedizin Greifswald Klinik für Anästhesiologie, IntensivmedizinNotfallmedizin und Schmerzmedizin
- Medizinische Hochschule Hannover Hospital - Zentrum Innere Medizin - Klinik fuer Pneumologie
- Universitätsklinikum Schleswig-Holstein - Klinik für Anästhesiologie und Operative Intensivmedizin
- Helios Klinikum Erfurt -Klinik fur Anaesthesie, Intensivmedizin und Schmerztherapie
- Universitatsklinikum Jena - Klinik für Anästhesiologie und Intensivmedzin
- Universitätsklinikum Hamburg Eppendorf Department Intensive Care Medicine
- St. Vincent's University Hospital
- Medical Center Leeuwarden
- Radboud University Nijmegen
- Canisius Wilhelmina Ziekenhuis
- Jeroen Bosch Ziekenhuis
- VU Medisch Centrum
- Medisch Spectrum Twente
- Erasmus Medisch Centrum
- Ikazia Ziekenhuis
- Gelre Ziekenhuizen - Hospital
- Hospital Universitario Germans Trias i Pujol Medicina Intensiva Hospital General,
- Hospital de La Santa Creu i Sant Pau
- Corporacio Sanitaria Parc Tauli
- Hospital Mutua de Terrassa
- Hospital Universitario Vall d'Hebron
- Hospital Universitario 12 de Octubre, Unidad de Cuidados Intensivos Hospital General
- Hospital Universitari de Tarragona Joan XXIII
- Royal Surrey County Hospital - Intensive Care Unit
- Royal Infirmary of Edinburgh
- Royal London Hospital
- University College London
- St James University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
0.4 mg/kg (250 U/kg) recAP
0.8 mg/kg (500 U/kg) recAP
1.6 mg/kg (1000 U/kg) recAP
Arm Description
1 hour IV infusion once daily for 3 days
1 hour IV infusion once daily for 3 days
1 hour IV infusion once daily for 3 days
1 hour IV infusion once daily for 3 days
Outcomes
Primary Outcome Measures
Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)
Primary endpoint is calculated as the average of the standardized endogenous creatinine clearance values over the first seven days between the placebo and 1.6 mg/kg recAP arm.
Standardized endogenous creatinine clearance is assessed on each days from D1 to Day 7 during a 6 +/- 1 hour period and calculated in mL/min as the mean creatinine clearance over the period. The study started with 4 treatment arms of which 0.4 mg/kg recAP and the 0.8 mg/kg recAP were dropped after the interim analysis. The number of the patients in the dropped arm are respectively 30 and 32. Therefore the statistical analysis has been performed only on the placebo and 1.6 mg/kg group.
Secondary Outcome Measures
Number of Participants Who Had Renal Replacement Therapy (RRT) During the Period Day 1 to Day 28, Inclusive
During the study the days on Renal Replacement Therapy (RRT) was recorded for each patients. During the first 7 days of the study (D1 to D7 included), patients were only allowed to receive continuous RRT, thereafter patients were also allowed to receive intermittent RRT. Standardization of RRT was attempted by providing guidelines to start and stop RRT (see protocol). Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02182440
Brief Title
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
Acronym
STOP-AKI
Official Title
A DB Four-Arm, Parallel Group, Proof of Concept, Dose-Finding Adaptive Phase 2a/2b RCT to Investigate the Safety, Tolerability and Efficacy and Effect on QoL of Human Recombinant Alkaline Phosphatase in Patients With Sepsis-Associated AKI
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 18, 2014 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
September 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AM-Pharma
Collaborators
PPD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.
Detailed Description
Design:
Adaptive trial with two stages and interim analysis
Stage 1: four arms; three dose groups and placebo. n=30/arm. (n=120)
Interim analysis based on 120 subjects, with continued recruitment, adding 11 subjects to Stage 1 safety population (n=131): to evaluate safety and select dose for stage 2
Stage 2: one dose group and placebo. N=85/arm. (n=170) Total n in the study: 301.
Primary objectives
To investigate the effect of recAP on renal function (measured creatinine clearance D1-D7 period, incidence and duration of renal replacement therapy (RRT) over 28 days, eGFR at D60 and D90) and related clinical parameters (ICU stay, Hospital stay, Mechanical ventilation over 28 days, SOFA and SAPS2 scores 28 days) in patients with SA-AKI.
To determine effective therapeutic dose(s) of recAP.
Secondary objectives
To investigate the safety and tolerability of recAP in patients with SA AKI. (assessed by independent Data Monitoring Board, adverse events over 90 days study period, laboratory values, ECG, physical examniations, vital signs, Anti Drug Antibodies)
To investigate the pharmacokinetic profile (PK) of recAP in a subset of patients (part 1, n=120) with SA AKI. (Population PK; AUC D1-7, Cmax, Cmin, Tmax, terminal T1/2)
To investigate the immunogenic potential of recAP in patients with SA AKI. (anti-drug antibodies at D14, D28, D60 and D90)
To investigate the effect on quality of life (using the EuroQol, EQ-5D) following study inclusion, at ICU discharge, and Day 90.
Other objectives
• To evaluate whether specific patient groups can be identified that benefit most from recAP treatment or patient groups that are non-responders
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
SA-AKI, Sepsis, AKI, Recombinant Alkaline Phosphatase, recAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 hour IV infusion once daily for 3 days
Arm Title
0.4 mg/kg (250 U/kg) recAP
Arm Type
Experimental
Arm Description
1 hour IV infusion once daily for 3 days
Arm Title
0.8 mg/kg (500 U/kg) recAP
Arm Type
Experimental
Arm Description
1 hour IV infusion once daily for 3 days
Arm Title
1.6 mg/kg (1000 U/kg) recAP
Arm Type
Experimental
Arm Description
1 hour IV infusion once daily for 3 days
Intervention Type
Biological
Intervention Name(s)
recAP
Other Intervention Name(s)
Recombinant Alkaline Phosphatase
Intervention Description
One hour infusions once daily for three days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 hour IV infusion once daily for 3 days
Primary Outcome Measure Information:
Title
Area Under the Time Corrected Endogenous Creatinine Clearance From Day 1 to Day 7 (AUC1-7)
Description
Primary endpoint is calculated as the average of the standardized endogenous creatinine clearance values over the first seven days between the placebo and 1.6 mg/kg recAP arm.
Standardized endogenous creatinine clearance is assessed on each days from D1 to Day 7 during a 6 +/- 1 hour period and calculated in mL/min as the mean creatinine clearance over the period. The study started with 4 treatment arms of which 0.4 mg/kg recAP and the 0.8 mg/kg recAP were dropped after the interim analysis. The number of the patients in the dropped arm are respectively 30 and 32. Therefore the statistical analysis has been performed only on the placebo and 1.6 mg/kg group.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Number of Participants Who Had Renal Replacement Therapy (RRT) During the Period Day 1 to Day 28, Inclusive
Description
During the study the days on Renal Replacement Therapy (RRT) was recorded for each patients. During the first 7 days of the study (D1 to D7 included), patients were only allowed to receive continuous RRT, thereafter patients were also allowed to receive intermittent RRT. Standardization of RRT was attempted by providing guidelines to start and stop RRT (see protocol). Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Time Frame
28 days
Other Pre-specified Outcome Measures:
Title
All-cause Mortality at Day 28
Description
Number of patients in the ITT set, who died in the period between day 1 to day 28. Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Time Frame
Day 28
Title
All-cause Mortality at Day 90
Description
Number of patients in the ITT set, who died in the period between Day 1 and Day 90 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Time Frame
Day 90
Title
Number of Participants Meeting at Least One MAKE 60 Criteria
Description
Make 60 is composed of patients that meet at least one of the following criteria at day 60:
had eGFR < 60 mL/min (calculated by using the CKD-EPI formula) or
became dialysis dependent up to Day 60 or
died prior to Day 60 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Time Frame
Day 60
Title
Number of Patients Who Meet at Least One of the MAKE 90 Criteria
Description
Make 90 includes patients who meet at least one of the following parameters at Day 90:
had eGFR <60 ml/min at Day 90, estimated by the CKD-EPI formula based on a serum creatinine or
was dialysis dependent up to Day 90 or
was hospitalized for a new episode of acute kidney injury prior to Day 90 or
died, prior to Day 90 Statistical analysis was only performed on the placebo and 1.6 mg/kg recAP arm due to the small number of patients treated with the doses of 0.4 mg/kg and 0.8 mg/kg recAP. Those two doses were dropped in part 2 of the study.
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent Form (patient, legal representative or independent investigator)
Age 18 to 85 years, inclusive
Is admitted to the ICU or Intermediate Care Unit
Has diagnosis of sepsis (< 96 hrs prior to first study drug), according to criteria defined by the American College of Chest Physicians/Society of Critical Care Medicine:
Has a proven or strongly suspected bacterial infection.
Has at least 2 of 4 SIRS criteria 72 hrs < screening and 96 hrs < first study drug
First diagnosis of AKI: AKI Stage 1 or greater, according to the AKIN criteria (time-window adjusted):
Increase in serum creatinine > 26.2 µmol/L (0.30 mg/dL) in 48 hrs prior to screening, or
Increase in serum creatinine to > 150% (> 1.5-fold) from reference creatinine value in 48 hrs prior to screening
Urinary output < 0.5 mL/kg/h for > 6 hours following adequate fluid resuscitation
Continuing AKI needs to be confirmed by a confirmative fluid corrected serum creatinine measure, or
When the AKI diagnosis was made according to the AKIN urine output criteria (urinary output < 0.5 mL/kg/h for > 6 hours), the oliguria or anuria should still meet the AKIN urine output criteria prior to randomization.
Exclusion Criteria:
Woman of childbearing potential with a positive pregnancy test, pregnant, or breastfeeding.
Weighs more than 115 kg (253 lb).
Has life support limitations.
Is known to be human immunodeficiency virus positive.
Has urosepsis.
Is already on dialysis (RRT) or anticipated to receive RRT within 24 hours after study drug dosing due to the underlying disease.
Is receiving immunosuppressant treatment or is on chronic high doses of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg) can be included.
Is expected to have rapidly fatal outcome (within 24 hours).
Has known, confirmed fungal sepsis.
Has advanced chronic liver disease, confirmed by a Child-Pugh score of 10 to 15.
Has acute pancreatitis with no established source of infection.
Has participated in another investigational study within 30 days prior to enrollment.
Is not expected to survive for 28 days due to medical conditions other than SA AKI, including cancer, end-stage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 30 days, end stage lung disease, and end stage liver disease.
Has known prior history of Chronic Kidney Disease with a documented estimated Glomerular Filtration Rate (eGFR) < 60 mL/min by Modification of Diet in Renal Disease MDRD or CKD-EPI formula, known GFR < 60 mL/min, or a known history of persistent creatinine level > 150 µmol/L (1.70 mg/dL) for reasons other than the current sepsis condition.
Has diagnosis of malaria or other parasite infections.
Has burns on > 20% of body surface.
Has had AKI diagnosis according to inclusion criteria > 24 hours prior to study drug administration.
Is anticipated to be treated with non-continuous RRT from Day 1 to Day 7.
During Day 1 to Day 7 continuous RRT is anticipated to be started or stopped not according to per protocol criteria.
The AKI is most likely attributable to other causes than sepsis, such as nephrotoxic drugs and renal perfusion-related.
Improvement in serum creatinine of at least 0.30 mg/dL or (26.2 µmol/L) prior to administration of the study drug.
Patients who use nephrotoxic medication and who fulfill the SA-AKI inclusion criteria at screening are not eligible if the use of this nephrotoxic medication is to continue when alternative, medically appropriate, non-nephrotoxic medication is available.
Has a history of known IV drug abuse.
Is an employee or family member of the investigator or study site personnel.
Has active hematological malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Arend, MD DiMD
Organizational Affiliation
AM Pharma BV
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter Pickkers, Prof MD. PhD
Organizational Affiliation
Department Intensive Care, Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Tampa General Hospital, Division Emergency Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Eastern Idaho Medical Consultants LLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
University of Texas Houston Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitätsklinik für Allgemeine und Chirurgische Intensivmedizin
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Hôpital Erasme
City
Brussels
State/Province
Brussel
ZIP/Postal Code
B-1070
Country
Belgium
Facility Name
CHU UCL Mont Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
University Hospital Ghent
City
Gent
State/Province
Oost Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Antwerpen
City
Antwerpen
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Cliniques Universitaires Saint Luc-UCL
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
B-1020
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
State/Province
Jihomoravský Kraj
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Oblastni nemocnice Kolin, a.s.
City
Kolin
ZIP/Postal Code
280 02
Country
Czechia
Facility Name
Fakultni nemocnice Plzen
City
Pilsen
ZIP/Postal Code
30460
Country
Czechia
Facility Name
Helsingin Yliopistollinen Keskussairaala
City
Helsinki
ZIP/Postal Code
FI-00290
Country
Finland
Facility Name
Kuopion Yliopistollinen Sairaala
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Tampereen yliopistollinen sairaala
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Hôpital Universitaire Dupuytren
City
Limoges
State/Province
Haute-Vienne
ZIP/Postal Code
87042
Country
France
Facility Name
Hôpital Charles Nicolle
City
Rouen
State/Province
Seine-Maritime
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hospitalier Departemental de Vendee
City
La Roche sur Yon
State/Province
Vendée
ZIP/Postal Code
85925
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier Victor Dupouy - hopital
City
Argenteuil
Country
France
Facility Name
CHRU Nantes - Hospital
City
Nantes
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
University Hospital Frankfurt, Anaesthesia, Intensive Care Medicine & Pain Therapy
City
Frankfurt am Main,
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitätsmedizin Greifswald Klinik für Anästhesiologie, IntensivmedizinNotfallmedizin und Schmerzmedizin
City
Greifswald
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17475
Country
Germany
Facility Name
Medizinische Hochschule Hannover Hospital - Zentrum Innere Medizin - Klinik fuer Pneumologie
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein - Klinik für Anästhesiologie und Operative Intensivmedizin
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Helios Klinikum Erfurt -Klinik fur Anaesthesie, Intensivmedizin und Schmerztherapie
City
Erfurt
State/Province
Thüringen
ZIP/Postal Code
99089
Country
Germany
Facility Name
Universitatsklinikum Jena - Klinik für Anästhesiologie und Intensivmedzin
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Hamburg Eppendorf Department Intensive Care Medicine
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Medical Center Leeuwarden
City
Leeuwarden
State/Province
Friesland
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Radboud University Nijmegen
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Canisius Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
's Hertogenbosch
State/Province
Noord-Brabant
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
VU Medisch Centrum
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Medisch Spectrum Twente
City
Enschede
State/Province
Overijssel
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Ikazia Ziekenhuis
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3083 AN
Country
Netherlands
Facility Name
Gelre Ziekenhuizen - Hospital
City
Apeldoorn,
ZIP/Postal Code
7334 DZ
Country
Netherlands
Facility Name
Hospital Universitario Germans Trias i Pujol Medicina Intensiva Hospital General,
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de La Santa Creu i Sant Pau
City
Barcelona
State/Province
Cataluna
ZIP/Postal Code
08025
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
State/Province
Cataluna
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
State/Province
Cataluña
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre, Unidad de Cuidados Intensivos Hospital General
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitari de Tarragona Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Royal Surrey County Hospital - Intensive Care Unit
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SB
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
St James University Hospital
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30357272
Citation
Pickkers P, Mehta RL, Murray PT, Joannidis M, Molitoris BA, Kellum JA, Bachler M, Hoste EAJ, Hoiting O, Krell K, Ostermann M, Rozendaal W, Valkonen M, Brealey D, Beishuizen A, Meziani F, Murugan R, de Geus H, Payen D, van den Berg E, Arend J; STOP-AKI Investigators. Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1998-2009. doi: 10.1001/jama.2018.14283.
Results Reference
derived
PubMed Identifier
27678541
Citation
Peters E, Mehta RL, Murray PT, Hummel J, Joannidis M, Kellum JA, Arend J, Pickkers P. Study protocol for a multicentre randomised controlled trial: Safety, Tolerability, efficacy and quality of life Of a human recombinant alkaline Phosphatase in patients with sepsis-associated Acute Kidney Injury (STOP-AKI). BMJ Open. 2016 Sep 27;6(9):e012371. doi: 10.1136/bmjopen-2016-012371.
Results Reference
derived
Learn more about this trial
A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI
We'll reach out to this number within 24 hrs