CompletedPhase 2

Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

Germany271 participantsStarted 2023-12-19

Plain-language summary

The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.

Who can participate

Age range18 Years

SexALL

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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):
✓. 1\. combined valve and CABG surgery; 2. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch)
✓. CABG with 3 or more distal anastomoses
✓. Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2
✓. Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter
✓. 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
✕. Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis
✕. 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

What they're measuring

Assessment of serum creatinine values

Timeframe: From Baseline to Day 5

Trial details

NCT IDNCT06168799

SponsorAM-Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-05

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