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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/NCT03050476




Registration number
NCT03050476
Ethics application status
Date submitted
24/01/2017
Date registered
13/02/2017
Date last updated
19/04/2024

Titles & IDs
Public title
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
Scientific title
Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
Secondary ID [1] 0 0
NUH-ALS-2015-04
Universal Trial Number (UTN)
Trial acronym
APPIRED-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Inflammation 0 0
Cardiopulmonary-bypass 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RESCAP®
Treatment: Drugs - placebo

Experimental: RESCAP® - Bolus of 1000 IU of bovine intestinal alkaline phosphatase on induction of anaesthesia, followed by an infusion with a sum of 10,000 IU/day over the next 24 or 96 hours.

Placebo Comparator: Placebo - Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours.


Treatment: Drugs: RESCAP®
intravenous application before, during, and for 24 or 96 hours after heart surgery

Treatment: Drugs: placebo
intravenous application before, during, and for 24 or 96 hours after heart surgery
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients with acute kidney injury
Timepoint [1] 0 0
90 days
Primary outcome [2] 0 0
reach haemodynamic stability
Timepoint [2] 0 0
7 days
Secondary outcome [1] 0 0
cost-related outcome
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
levels of a set of inflammatory markers
Timepoint [2] 0 0
4 days

Eligibility
Key inclusion criteria
- Undergoing cardiac surgery with planned cardiopulmonary bypass

- Additive Euroscore II = 3 OR at least 3 surgical cardiac interventions are planned

- Ability to provide informed consent (not incapacitated)
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Already on renal replacement therapy

- Patients with chronic kidney disease defined as estimated glomerular filtration rate
[eGFR] < 30 mL/min/1.73 m2 [ CKD stage > 3 ]

- Patients who are pregnant or lactating

- Concurrent enrollment in another clinical trial

- Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or
vegan

- Patients with ongoing infections or current use of steroids

- Patients with high-risk emergency surgery or with follow-up procedures already planned
at admission (like e.g. TEVAR)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
1250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Melbourn
Recruitment hospital [1] 0 0
Dept. Cardiothoracic Surgery , Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
VIC 3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Belgium
State/province [4] 0 0
Genk
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Hasselt
Country [7] 0 0
Germany
State/province [7] 0 0
Bavaria
Country [8] 0 0
Germany
State/province [8] 0 0
Leipzig
Country [9] 0 0
Italy
State/province [9] 0 0
Roma
Country [10] 0 0
Malaysia
State/province [10] 0 0
Kuala Lumpur
Country [11] 0 0
Netherlands
State/province [11] 0 0
Limburg
Country [12] 0 0
Netherlands
State/province [12] 0 0
Eindhoven
Country [13] 0 0
Portugal
State/province [13] 0 0
Lisboa
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Kazan
Country [15] 0 0
Russian Federation
State/province [15] 0 0
Saint Petersburg
Country [16] 0 0
Russian Federation
State/province [16] 0 0
St Petersburg
Country [17] 0 0
Singapore
State/province [17] 0 0
Singapore
Country [18] 0 0
Spain
State/province [18] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alloksys Life Sciences B.V.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Aix Scientifics
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute
kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03050476
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ruud Brands, PhD
Address 0 0
Alloksys Life Sciences BV . President
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ruud Brands, PhD
Address 0 0
Country 0 0
Phone 0 0
+31 647 228 395
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03050476