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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03050476
Other study ID # NUH-ALS-2015-04
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 1, 2017
Est. completion date March 31, 2026

Study information

Verified date April 2024
Source Alloksys Life Sciences B.V.
Contact Ruud Brands, PhD
Phone +31 647 228 395
Email ruud@alloksys.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1250
Est. completion date March 31, 2026
Est. primary completion date September 30, 2025
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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) 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


Intervention

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

Locations

Country Name City State
Australia Dept. Cardiothoracic Surgery , Monash Medical Centre Clayton Melbourne
Austria Division of Cardiac Surgery, Department of Surgery, LKH Medical University of Graz Graz
Austria MedUniWien / AKH-Wien Wien
Belgium Department of Intensive Care, CHU Saint-Pierre, Université Libre de Bruxelles (ULB) Brussels
Belgium Department of Intensive Care, Hôpital Universitaire de Bruxelles (HUB) Brussels
Belgium Hospital ZOL Genk
Belgium Dept. of Anesthesia and Intensive Care, AZ Maria Middelares Gent
Belgium Jessa Ziekenhuis,Campus Virga Jesse Hasselt
Germany Klinik für Herzchirurgie, Universitätsklinik Leipzig
Germany German Heart Centre Munich, Dept.Cardio-Vascular Surgery Munich Bavaria
Italy Policlinico Gemelli, Institute Cardiology Roma
Italy U.O.C. Cardiochirurgia e Trapianti di Cuore, Azienda Ospedaliera San Camillo Forlanini Roma
Malaysia Institut Jantung Negara (IJN , Natl. Heart Inst.) Kuala Lumpur
Netherlands Catharina Ziekenhuis, Cathreine R&D, Heartcentre Eindhoven
Netherlands Dept. Cardiothoracic Surgery, Maastricht University Medical Centre Maastricht Limburg
Portugal Hospital de Santa Marta Lisboa
Russian Federation State Autonomous Healthcare Institution "Interregional Clinical Diagnostic Center" Kazan
Russian Federation Federal State Budgetary Military Educational Institution of the Higher Education Saint Petersburg
Russian Federation Almazov Heart Center St Petersburg
Singapore National University Hospital (NUH), Singapore
Spain Jefe de Servicio de Cirugía Cardiovascular, Hospital Universitario La Princesa Madrid

Sponsors (2)

Lead Sponsor Collaborator
Alloksys Life Sciences B.V. Aix Scientifics

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Germany,  Italy,  Malaysia,  Netherlands,  Portugal,  Russian Federation,  Singapore,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 90 days
Primary reach haemodynamic stability Demonstrate that RESCAP® intervention reduces the time at ICU to reach haemodynamic stability 7 days
Secondary cost-related outcome Cost (SGD) incurred on renal replacement therapy, ICU and hospital stay 30 days
Secondary levels of a set of inflammatory markers IL-6, IL-8, IL-10, IL-17, TNF-alpha 4 days
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