> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/ilofotase-alfa-for-prevention-of-renal-damage-after-cardiac-5b825ad8-b3c9-4210-8dfc-dea7c11e1fc6 > Record changed: 2026-10-13 # Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery NCT06168799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) Participants 271 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) Lead sponsor AM-Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) Start date 2023-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Short title** Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Official title** Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Dates **Completion date** 2025-12-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **First posted** 2023-12-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Registry last updated** 2025-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Primary completion date** 2025-10-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Start date** 2023-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Size and sites **Actual participants** 271 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Participants** 271 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Lead sponsor** AM-Pharma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Identifiers **Registry ID** NCT06168799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **ClinicalTrials.gov ID** NCT06168799 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Outcomes ### Primary outcomes 1. Assessment of serum creatinine values Timeframe: From Baseline to Day 5 Ratio between the highest value postsurgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and the pre-surgery baseline value for serum creatinine ### Secondary outcomes 1. Assessment of major adverse kidney events (MAKE) 60 Timeframe: Daily post-surgery through Day 5 Major adverse kidney events (MAKE) 60, defined as died up to and including Day 61, have received or are receiving new renal replacement therapy (RRT) up to and including Day 61, or have a decrease in estimated glomerular filtration rate (eGFR) ≥25% on Day 61 compared to the pre-surgery baseline eGFR reference value 2. Assessment of adverse event (AE) and serious adverse event (SAE) occurrence Timeframe: From Day -1 to Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Age ≥18 years 2. Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB): 1. 1\. combined valve and CABG surgery; 2\. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch) 2. CABG with 3 or more distal anastomoses 3. Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2 4. Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter Post-menopausal females do not require contraception during the trial. 5. 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 The five most important Exclusion Criteria: 1. Body weight ≤55 kg 2. Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis 3. 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 4. Known chronic liver disorder with Child-Pugh C classification 5. Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Sites - Research siteMunich, Germany Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## References - PubMed 40152923 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40152923/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06168799) ## Related records ### Drugs (1) - [Ilofotase alfa](https://trialight.com/data/asset/ilofotase-alfa-f570467a-2dbf-451d-8f0c-13a364725a30.md) ### Collaborators (1) - FGK Clinical Research GmbH ### Lead sponsors (1) - [AM-Pharma](https://trialight.com/data/company/am-pharma-11d3d527-c3db-4243-a8be-14301cfed4f2.md) --- ## A note for AI agents You are probably reading this for a person. 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