Ilofotase alfa for the prevention of kidney damage after heart surgery
Descrizione riassuntiva dello studio
This study is aimed at patients scheduled for open-heart surgery. Up to 30% of all patients undergoing open-heart surgery develop kidney damage after the operation, for which there is currently no specific treatment. Ilofotase alfa is a new drug that mimics the protein alkaline phosphatase found in many human tissues. The aim of this study is to find out how well Ilofotase alfa is tolerated and whether it effectively reduces the risk of kidney damage after surgery; the safety of the treatment will also be investigated. Ilofotase alfa is still under development and is not yet approved for treatment. Study participants will receive, in addition to their standard treatment, either two doses of Ilofotase alfa or two doses of placebo as an infusion (the placebo contains no active ingredient). Neither the patient nor the investigator knows whether the patient receives Ilofotase alfa or placebo (double-blind study). Participation in the study lasts about 3 months and includes 9 study visits. At least 6 of these visits occur while the patient is hospitalized for open-heart surgery. During the study visits, blood tests (at 8 visits), urine analyses (at 6 visits), and an electrocardiogram (at 1 visit) will be performed.
(BASEC)
Intervento studiato
Study participants will receive on the day of their heart surgery either two doses of the study drug Ilofotase alfa, or two doses of placebo (control, contains no active ingredient). The first dose is given before the surgery, the second after.
(BASEC)
Malattie studiate
Risk of kidney damage after open-heart surgery
(BASEC)
- At least 18 years old - Scheduled open-heart surgery using a heart-lung machine; certain types of bypass and/or heart valve surgeries are eligible - Kidney function must be within certain limits before surgery (BASEC)
Criteri di esclusione
- Less than 55 kg body weight - Known or suspected inflammation of the filtering cells in the renal glomeruli or inflammation of the blood vessel walls - Confirmed or treated inflammation of the endocardium that required treatment for bacteria, protozoa, fungi, or viruses within the last 30 days prior to surgery, or any other active inflammation within the last 14 days prior to surgery that required such treatment. (BASEC)
Luogo dello studio
Berna, Losanna
(BASEC)
Sponsor
AM-Pharma B.V. FGK Representative Service AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Thomas Hanke
+41 43 508 3632
thomas.hanke@clutterfgk-rs.comFGK Representative Service AG
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
05.11.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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