Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

NCT06168799 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: AP-recAP-CSA-RD-02-01WHO Universal Trial NumberEU Clinical Trial Number
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 1

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)

• Assessment of serum creatinine values

  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

  From Baseline to Day 5

Secondary Outcomes (2)

• Assessment of major adverse kidney events (MAKE) 60

  Daily post-surgery through Day 5

• Assessment of adverse event (AE) and serious adverse event (SAE) occurrence

  From Day -1 to Day 28

Other Outcomes (6)

• AUC of AKI

  From Day 1 to Day 5

• Incidence of KDIGO AKI

  From Day 1 to Day 5

• Assessment of surgery-related complications occurrence

  From Day 1 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 (1)

Research site

Munich, Germany

Location

Related Publications (1)

• 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

Study Officials

• Pickkers, Prof, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

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: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)