Clinical trial • Phase III • Immunology|Cardiology
ALKALINE PHOSPHATASE, BOVINE for Systemic inflammation due to cardiopulmonary bypass|Acute kidney injury
Phase III trial of ALKALINE PHOSPHATASE, BOVINE for Systemic inflammation due to cardiopulmonary bypass|Acute kidney injury.
Overview
- Trial Therapeutic Area
- Immunology|Cardiology
- Trial Disease
- Systemic inflammation due to cardiopulmonary bypass|Acute kidney injury
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 24-01-2025
- First CTIS Authorization Date
- 30-01-2025
Trial design
The placebo is identical with the IMP, but without active substance (placebo comparator; no dose/schedule specified for placebo beyond being identical to IMP without active substance).-controlled, adaptive Phase III trial across 7 sites in Belgium, Austria.
- Comparator
- The placebo is identical with the IMP, but without active substance (placebo comparator; no dose/schedule specified for placebo beyond being identical to IMP without active substance).
- Adaptive
- True (stopping rules specified: stop administering placebo but continue experimental drug if AKI or mortality significantly lower in experimental group; stop if all-cause mortality, cardiac mortality, AKI, or primary compound outcome significantly higher in experimental group; stop if >5% of patients have a serious adverse/allergic reaction).
- Target Sample Size
- 500
- Trial Duration For Participant
- 90
Eligibility
Recruits 500 No vulnerable population selected. Participants must be legal adults (> 21 years in Singapore) and "Ability to provide informed consent (not incapacitated)" is required; "Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol.".
- Pregnancy Exclusion
- Patients who are pregnant or lactating
- Vulnerable Population
- No vulnerable population selected. Participants must be legal adults (> 21 years in Singapore) and "Ability to provide informed consent (not incapacitated)" is required; "Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol."
Inclusion criteria
- {"criterion_text":"- > 21 years of age (legal adult in Singapore)"}
- {"criterion_text":"- Undergoing cardiac surgery with planned cardiopulmonary bypass"}
- {"criterion_text":"- EuroSCORE II >= 3"}
- {"criterion_text":"- Ability to provide informed consent (not incapacitated)"}
- {"criterion_text":"- Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol."}
Exclusion criteria
- {"criterion_text":"- Already on renal replacement therapy"}
- {"criterion_text":"- Patients with chronic kidney disease defined as urinary albumin excretion of ≥30 mg/day, or equivalent or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2 for > 3 months."}
- {"criterion_text":"- Patients who are pregnant or lactating"}
- {"criterion_text":"- Concurrent enrolment in another clinical trial"}
- {"criterion_text":"- Known allergic reaction to bovine alkaline phosphatase"}
- {"criterion_text":"- Patient with ongoing infections or current use of steroids"}
- {"criterion_text":"- Patient with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g., TEVAR)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- • Stop administering placebo but continue with experimental drug if AKI (defined by AKIN) is significantly lower in the experimental group or mortality is significantly lower in the experimental group.","definition_or_measurement_approach":"AKI defined by AKIN criteria (rise in serum creatinine by 0.3 mg/dl or 26 μmol/L in 48 hours or ≥50% increase in serum creatinine, or urine output < 0.5 ml/kg/hour for 6 hours). AKI occurrence checked within 30 days and additionally after 90 days after surgery. (As described in main objective.)"}
- {"endpoint_text":"- • Stop if all cause mortality, cardiac mortality, acute kidney injury, or the primary compound outcome is significantly higher in the experimental group","definition_or_measurement_approach":"All-cause and cardiac mortality assessed post-surgery; acute kidney injury assessed per AKIN criteria (see above). Primary severity/stability assessed using SOFA score over 12 days while in ICU and compared after 72 hours."}
- {"endpoint_text":"- • Stop if more than 5% of patients have a serious adverse/allergic reaction to the administration of the drug","definition_or_measurement_approach":"Safety monitoring of serious adverse events and allergic reactions; threshold triggered if >5% of patients experience serious adverse/allergic reaction to drug administration."}
Recruitment
- Planned Sample Size
- 500
- Recruitment Window Months
- 99
- Consent Approach
- Written informed consent required prior to participation. "Ability to provide informed consent (not incapacitated)" is an inclusion criterion and "Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol." Subject information and informed consent form documents are provided (languages available in repository: English, French, Dutch for Belgium; German and English variants for Austria).
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 500
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-01-2025
- Latest Decision Or Authorization Date
- 30-01-2025
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 75
Sites
- Site Name
- Hopital Erasme
- Department Name
- Department of Intensive Care
- Contact Person Name
- Fabio Silvio Taccone
- Contact Person Email
- fabio.taccone@ulb.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- cardiac surgery
- Contact Person Name
- Abdullah Kaya
- Contact Person Email
- Abdullah.Kaya@jessazh.be
- Site Name
- CHU Saint Pierre
- Department Name
- Department of Intensive Care
- Contact Person Name
- Antoine Herpain
- Contact Person Email
- Antoine.Herpain@ulb.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Dept. of Anesthesia and Intensive Care
- Contact Person Name
- Jan Heerman
- Contact Person Email
- Jan.Heerman@AZMMSJ.be
Austria
- Earliest CTIS Part Ii Submission Date
- 09-01-2025
- Latest Decision Or Authorization Date
- 28-08-2025
- Processing Time Days
- 231
- Number Of Sites
- 3
- Number Of Participants
- 425
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Department of Surgery
- Contact Person Name
- Martin Andreas
- Contact Person Email
- Martin.Andreas@medunigraz.at
- Site Name
- Noe LGA Gesundheit Region Mitte GmbH
- Department Name
- Klinische Abteilung für Herzchirurgie
- Contact Person Name
- Dominik Wiedemann
- Contact Person Email
- Dominik.Wiedemann@stpoelten.lknoe.at
- Site Name
- Medical University Of Vienna
- Department Name
- Klinische Abteilung für Herzchirurgie
- Contact Person Name
- Julia Riebandt
- Contact Person Email
- Julia.Riebandt@meduniwien.ac.at
Sponsor
Primary sponsor
- Full Name
- Alloksys Life Sciences B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- RESCAP iv
- Active Substance
- ALKALINE PHOSPHATASE, BOVINE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Route
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Authorisation Status
- prodAuthStatus: 1
- Maximum Dose
- maxDailyDoseAmount: 13300 (IU); maxTotalDoseAmount: 190; doseUom: IU international unit(s); doseUomTotal: IU/Kg iu/kilogram
- Investigational Product Name
- The placebo is identical with the IMP, but without active substance
- Modality
- Other
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