Open Heart SurgeryPhase 2NCT06168799
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
A Phase 2 study testing Ilofotase alfa in people with Open Heart Surgery, run by AM-Pharma at 13 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- Ilofotase alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 271 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 19 Dec 2023to 3 Dec 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Post-menopausal females 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
- The five most important 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
Who cannot join
None listed.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Germany4 sites
Universität Duisburg-Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie
Essen
Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen
Munich
Westfaelische Wilhelms-Universitaet Muenster
Münster
Universitätsklinikum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen
Tübingen
Belgium3 sites
Ziekenhuis Oost Limburg
Genk
Universitair Ziekenhuis Gent
Ghent
Algemeen Ziekenhuis Delta
Roeselare
Netherlands3 sites
Academisch Medisch Centrum Amsterdam
Amsterdam
Stichting Radboud University Medical Center
Nijmegen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam
Switzerland2 sites
Universitätsspital Bern Universitätsklinik für Herzchirurgie
Bern
Centre hospitalier universitaire vaudois (CHUV)
Lausanne
About this study
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
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.
Read the detailed description
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, 2-arm parallel group design trial in patients at risk for renal damage following open heart surgery. After screening and baseline assessments, eligible patients will be randomized 1:1 to either 2 doses of 128 mg ilofotase alfa, or 2 doses of placebo control. Randomization will be stratified by baseline eGFR and type of surgery. The patient will be treated with the investigational product (ilofotase alfa or placebo) at the same day before and after the surgery (Day 1). Follow-up clinic visits will be performed daily up to Day 5 for efficacy, safety, and pharmocokinetics assessments. A safety follow-up can be performed by telephone at Day 28. At Day 61, an end of trial visit will be done at site for efficacy, safety, and anti-drug antibodies assessments.
- Conditions
- Open Heart Surgery
- Being tested
- Ilofotase alfa, Placebo
- Keywords
- Renal, Kidney, Cardiac, CPB, CABG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ilofotase alfaDrug
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)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Ilofotase alfa | Experimental | Not described Receives: Drug: Ilofotase alfa |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline (Day -1/1) to Day 5
Secondary outcomes (2)
Assessment of Major Adverse Kidney Events (MAKE) 60
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. With Day 1 being the day of surgery.
Measured: 60 days
(Serious) Adverse Events up to Day28
All AEs that occured up to and including Day 28 or patient's trial completion, whichever occurs first.
Measured: Day1 to Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start19 Dec 2023
- Primary completion5 Oct 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- AM-Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Pickkers, Prof, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168799
- Sponsor's protocol ID
- AP-recAP-CSA-RD-02-01
- Other IDs
- WHO Universal Trial Number, EU Clinical Trial Number
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2023
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42766022Tellez 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.
PubMed 40152923