Ilofotase alfa for prevention of renal damage after cardiac surgery

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 212

Inclusion Criteria

Age =18 years, Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB): a. 1) combined valve and CABG surgery 2) aortic valve plus aortic root and/or ascending aorta (excluding aortic arch) b. CABG with 3 or more distal anastomoses, Screening eGFR =25 mL/min/1.73m2 and =65 mL/min/1.73m2 (calculated at Screening using sCreat which can be maximally 28 days old and the 2021 CKD-EPI formula without race correction (eGFR = 142 × Min(Scr/?,1)a × Max(Scr/?,1)-1.200 × 0.9938Age [× 1.012 if female]), Female patients of childbearing potential agreeing to use an effective contraception method within IP treatment and 14 days thereafter. Post-menopausal females (i.e., >60 years of age or no menses for 12 consecutive months without an alternative medical cause with confirmatory follicle-stimulating hormone level of =40 mIU/mL) do not require contraception during the trial., Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter

Exclusion Criteria

Body weight =55 kg, Not willing and able to understand the information on the nature, the scope, and the relevance of the trial and to provide voluntary, written informed consent to participate in the trial before any trial related procedures, Pregnant or nursing women, Known or suspected hypersensitivity to ilofotase alfa or any components of the formulation used, Any previous organ transplantation, Congenital heart disease, Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery, History of RRT, Cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP) within 24 hours prior to surgery, A requirement for any of the following within one week prior to surgery: implantation of a defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support, Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery, Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis, Ongoing sepsis (as defined by SEPSIS-3, the Third International Consensus Definitions for Sepsis and Septic Shock) within the past 2 weeks or, in the opinion of the investigator, an untreated diagnosed clinically significant infection (viral or bacterial) prior to or at Screening and before randomization, Medical condition which requires active immunosuppressive treatment (daily steroid doses of =10 mg are allowed), Employees or relatives of the sponsor or the investigator, Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery, Known chronic liver disorder with Child-Pugh C classification, Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest, Planned surgery for aortic dissection, Use of left ventricular assist device (LVAD), or intra-aortic balloon pump or other cardiac devices, within 7 days prior to surgery, Received any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Day 1 or planned or current participation in another interventional study until the EoT visit has been completed, Previous receipt of ilofotase alfa

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of ilofotase alfa on renal function;Secondary Objective: To assess the safety and tolerability of ilofotase alfa in patients undergoing open chest heart surgery, Pharmocokinetics: To investigate the pharmacokinetic (PK) properties of ilofotase alfa;Primary end point(s): Ratio between the highest value post-surgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and the pre-surgery baseline value for serum creatinine (sCreat)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Incidence rate of adverse events (AEs) and serious AEs through Day 28;Secondary end point(s):Pharmacokinetics: Population (Pop)PK