Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

NCT06168799 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: AP-recAP-CSA-RD-02-01WHO Universal Trial NumberEU Clinical Trial Number
• Study Type: interventional
• Target: 271
• Locations: 5 countries
• Sites: 13

Brief 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.

Conditions

Open Heart Surgery

Keywords

Renal; Kidney; Cardiac; CPB; CABG

Outcome Measures

Primary Outcomes (1)

• Serum Creatinine Level Ratio

  Ratio between the highest serum creatinine value post-surgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and baseline serum creatinine (pre-surgery, Day -1/Day 1). The values at post-surgery Day 1 and Days 2, 3, 4, and 5 compared to the value at baseline (Day -1/Day 1) are used to calculate the serum creatinine ratio. The reported means and standard deviations are based on patient-level ratios and include observed and imputed values.

  From Baseline (Day -1/1) to Day 5

Secondary Outcomes (2)

• Assessment of Major Adverse Kidney Events (MAKE) 60

  60 days

• (Serious) Adverse Events up to Day28

  Day1 to Day28

Other Outcomes (3)

• Cumulative AKI Severity (Area Under the Curve)

  From Day 1 to Day 5

• Number of Participants With KDIGO AKI

  From Day 1 to Day 5

• Assessment of Length of Stay in the Intensive Care Unit

  From Baseline to Day 28

Study Arms (2)

Ilofotase alfa

EXPERIMENTAL

Drug: Ilofotase alfa

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

After dilution of the concentrate, the investigational medicinal product will be administered by intravenous infusion for 1 hour at the same day before and after the surgery (Day 1)

Placebo

Ilofotase alfa DRUG

After dilution of the concentrate, the investigational medicinal product will be administered by intravenous infusion for 1 hour at the same day before and after the surgery (Day 1)

Ilofotase alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB):
• \. 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
• Post-menopausal females do not require contraception during the trial.

You may not qualify if:

• 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

Sponsors & Collaborators

• AM-Pharma: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (13)

Ziekenhuis Oost Limburg

Genk, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Algemeen Ziekenhuis Delta

Roeselare, Belgium

Location

Universität Duisburg-Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie

Essen, Germany

Location

Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen

Munich, Germany

Location

Westfaelische Wilhelms-Universitaet Muenster

Münster, Germany

Location

Universitätsklinikum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen

Tübingen, Germany

Location

Academisch Medisch Centrum Amsterdam

Amsterdam, Netherlands

Location

Stichting Radboud University Medical Center

Nijmegen, Netherlands

Location

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Rotterdam, Netherlands

Location

Universitätsspital Bern Universitätsklinik für Herzchirurgie

Bern, Switzerland

Location

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Switzerland

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

Related Publications (2)

• Mourisse L, Ostermann M, Thiessen S, Dumoulin A, Vlaar APJ, Hoste E, Mosbahi S, Schneider A, Zarbock A, Boehm J, Rosenberger P, Thielmann M, Dubois E, Powell-Tuck J, Baig K, Renette W, Meex I, Klop-Rhiel M, Opschoor K, Vandenberghe W, Siepe M, Strauss C, Wirth F, Winkel M, Hof L, Kraan M, Bernholz J, Pickkers P; study team. A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery. Intensive Care Med. 2026 Sep 21. doi: 10.1007/s00134-026-08596-y. Online ahead of print.

  PMID: 42766022 DERIVED

• Tellez Garcia JM, Steenvoorden T, Bemelman F, Hilhorst M, Tammaro A, Vogt L. Purinoreceptor P2X7 in Extracellular ATP-Mediated Inflammation through the Spectrum of Kidney Diseases and Kidney Transplantation. J Am Soc Nephrol. 2025 Mar 28;36(9):1823-1843. doi: 10.1681/ASN.0000000711.

  PMID: 40152923 DERIVED

Results Point of Contact

• Title: Pickkers, Prof, MD, PhD
• Organization: Radboud UMC - Department Intensive Care

peter.pickkers@radboudumc.nl

+31 (0)24 361 11 11

Study Officials

• Pickkers, Prof, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 19, 2023
• Primary Completion: October 5, 2025
• Study Completion: December 3, 2025
• Last Updated: September 29, 2026
• Results First Posted: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); NL (3); CH (2); GB (1); BE (3)