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Recruiting Phase 2, Phase 3 NCT03050476

Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

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Trial Parameters

Condition Systemic Inflammation
Sponsor Alloksys Life Sciences B.V.
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 1,250
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2017-11-01
Completion 2025-09-30
Interventions
RESCAP®placebo

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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.

Eligibility Criteria

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)

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