Systemic InflammationPhase 2/3APPIRED-IIINCT03050476
Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase
A Phase 2/3 study testing RESCAP® in people with Systemic Inflammation and Cardiopulmonary-bypass, run by Alloksys Life Sciences B.V. at 21 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Systemic Inflammation, Cardiopulmonary-bypass
- What is being tested?
- RESCAP®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,250 participants
- Where
- 21 sitesin 11 countries
- Study dates
- 1 Nov 2017to 31 Mar 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
21 sites in 11 countries.
21 sites in 11 countries
Belgium5 sites, 4 recruiting
- Not yet recruiting
Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels, 1000
Antoine Herpain, MD, +32 2 535 4912, Antoine.Herpain@stpierre-bru.be
- Not yet recruiting
Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB)
Brussels, 1070
Fabio S Taccone, MD, PhD, + 32 25 555 587, fabio.taccone@ulb.be
- Suspended
Hospital ZOL
Genk, 3600
- Recruiting
Dept. of Anesthesia and Intensive Care, AZ Maria Middelares
Ghent, 9000
Jan Heerman, Dr., +32 9 246 17 21, Jan.Heerman@AZMMSJ.be
- Recruiting
Jessa Ziekenhuis,Campus Virga Jesse
Hasselt, 3500
Alaaddin Yilmaz, Dr., +32 11 - 309060, Alaaddin.Yilmaz@jessazh.be
Russia3 sites
- Terminated
State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center"
Kazan', 420101
- Terminated
Federal State Budgetary Military Educational Institution of the Higher Education
Saint Petersburg, 194044
- Terminated
Almazov Heart Center
Saint Petersburg, 197341
Austria2 sites, 2 recruiting
- Not yet recruiting
Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz
Graz, 8036
Heinrich Mächler, Prof. Dr., heinrich.maechler@medunigraz.at
- Recruiting
MedUniWien / AKH-Wien
Vienna, 1090
Julia Riebandt, PD. Dr., +43-1-40400-69660, Julia.Riebandt@meduniwien.ac.at
Günther Laufer, Univ.Prof.Dr, guenther.laufer@meduniwien.ac.at
Germany2 sites, 1 recruiting
- Suspended
Klinik für Herzchirurgie, Universitätsklinik
Leipzig, 04289
- Not yet recruiting
German Heart Centre Munich, Dept.Cardio-Vascular Surgery
Munich, Bavaria, 80636
Hendrik Ruge, Dr., +49 89 1218 1510, ruge@dhm.mhn.de
Italy2 sites, 2 recruiting
- Not yet recruiting
U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
Antonio Lio, Dr, +39 32 0228 4282, antoniolio@hotmail.it
- Not yet recruiting
Policlinico Gemelli, Institute Cardiology
Roma, 00168
Massimo Massetti, Prof.MD, +39 06 - 3015 - 8762, Massimo.Massetti@unicatt.it
Netherlands2 sites
- Terminated
Catharina Ziekenhuis, Cathreine R&D, Heartcentre
Eindhoven, 5623 EJ
- Suspended
Dept. Cardiothoracic Surgery, Maastricht University Medical Centre
Maastricht, Limburg, 6229 HX
Australia1 site
- Terminated
Dept. Cardiothoracic Surgery , Monash Medical Centre
Clayton, Melbourne, VIC 3168
Malaysia1 site
- Terminated
Institut Jantung Negara (IJN , Natl. Heart Inst.)
Kuala Lumpur, 50400
Portugal1 site, 1 recruiting
- Not yet recruiting
Hospital de Santa Marta
Lisbon, 1169-024
José Fragata, Prof.MD PhD, +351 21 359 41 06, jigFragata@gmail.com
Pedro Coelho, MD, pedropirescoelho@gmail.com
Singapore1 site
- Terminated
National University Hospital (NUH),
Singapore, 119228
Spain1 site, 1 recruiting
- Not yet recruiting
Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa
Madrid, 28006
Guillermo Reyes Copa, Prof. Dr., +34 915 202 268, guillermo_reyes_copa@yahoo.es
About this study
Official title: Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
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.
Read the detailed description
After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.
- Conditions
- Systemic Inflammation, Cardiopulmonary-bypass
- Being tested
- RESCAP®, placebo
- Keywords
- side-effects, heart-lung machine, alkaline phosphatase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESCAP®Drug
intravenous application before, during, and for 24 or 96 hours after heart surgery
placeboDrug
intravenous application before, during, and for 24 or 96 hours after heart surgery
| Study group | Role | What they receive |
|---|---|---|
| RESCAP® | Experimental | 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. Receives: Drug: RESCAP® |
| Placebo | Placebo comparator | Bolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with acute kidney injury
AKIN criteria: Rise in serum creatinine of by 0.3 mg/dl or 26 µmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of more than 50 percent or a drop in urine output to 0.5 ml/kg/hour for 6 hours
Measured: 90 days
reach haemodynamic stability
Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability
Measured: 7 days
Secondary outcomes (2)
cost-related outcome
Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay
Measured: 30 days
levels of a set of inflammatory markers
IL-6, IL-8, IL-10, IL-17, TNF-alpha
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 Nov 2017
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alloksys Life Sciences B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Ruud Brands, PhD, Study chair, Alloksys Life Sciences BV . PresidentDominik Wiedemann, Prof.Dr., Principal investigator, Universitätsklinikum St. Pölten, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050476
- Sponsor's protocol ID
- NUH-ALS-2015-04
- Acronym
- APPIRED-III
- Status last verified
- Apr 2024
- First submitted
- 24 Jan 2017
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Oxidative Stress-induced Ischemic Injury- and Systemic Inflammation Complications During and After Invasive Cardiac Surgery With Alkaline Phosphatase (APPIRED III)
- ClinicalTrials.gov ID
- NCT03050476
- Acronym / sponsor ID
- APPIRED-III / NUH-ALS-2015-04
- Conditions
- Systemic Inflammation, Cardiopulmonary-bypass
- Keywords
- side-effects, heart-lung machine, alkaline phosphatase
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,250 participants (estimated)
- Lead sponsor
- Alloksys Life Sciences B.V.Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After cardiac surgery under cardiopulmonary bypass (CPB) patients often show impairments of the immune system. Compared to placebo, CPB patients given alkaline phosphatase will have reduced composite endpoint of acute kidney injury (AKI), late extubation, gastrointestinal or neurological complications within 7 days and AKI within 90 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESCAP® | Experimental | Drug: 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 | Placebo comparator | Drug: placeboBolus of of media on induction of anaesthesia, followed by an infusion of media over the next 24 or 96 hours. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESCAP®intravenous application before, during, and for 24 or 96 hours after heart surgery | Drug | RESCAP® |
| placebointravenous application before, during, and for 24 or 96 hours after heart surgery | Drug | Placebo |
Primary outcome
Number of patients with acute kidney injury
Time frame: 90 days
AKIN criteria: Rise in serum creatinine of by 0.3 mg/dl or 26 µmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of more than 50 percent or a drop in urine output to 0.5 ml/kg/hour for 6 hours
reach haemodynamic stability
Time frame: 7 days
Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability
2 secondary outcomes
cost-related outcome
Time frame: 30 days
levels of a set of inflammatory markers
Time frame: 4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruud Brands, PhD study chair
Alloksys Life Sciences BV . President
Dominik Wiedemann, Prof.Dr. principal investigator
Universitätsklinikum St. Pölten, Austria
21 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RESCAP® in people with Systemic Inflammation and Cardiopulmonary-bypass, run by Alloksys Life Sciences B.V. at 21 sites in 11 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Belgium, Russia, Austria, Germany, Italy and 6 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruud Brands, PhD (+31 647 228 395, ruud@alloksys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with acute kidney injury (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.