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COMPLETED
NCT06168799
PHASE2

Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

Sponsor: AM-Pharma

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

271

Start Date

2023-12-19

Completion Date

2025-12-03

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Ilofotase alfa

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)

DRUG

Placebo

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)

Locations (13)

Ziekenhuis Oost Limburg

Genk, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Algemeen Ziekenhuis Delta

Roeselare, Belgium

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

Essen, Germany

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

Munich, Germany

Westfaelische Wilhelms-Universitaet Muenster

Münster, Germany

Universitätsklinikum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen

Tübingen, Germany

Academisch Medisch Centrum Amsterdam

Amsterdam, Netherlands

Stichting Radboud University Medical Center

Nijmegen, Netherlands

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Rotterdam, Netherlands

Universitätsspital Bern Universitätsklinik für Herzchirurgie

Bern, Switzerland

Centre hospitalier universitaire vaudois (CHUV)

Lausanne, Switzerland

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom