Clinical Research Directory
Browse clinical research sites, groups, and studies.
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
Sponsor: AM-Pharma
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
Conditions
Interventions
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)
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