Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

Open Heart Surgery Clinical Trial

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

Status Recruiting

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Open Heart Surgery

• NCT number: NCT06168799
• Study type: Interventional
• Source: AM-Pharma
• Contact: Hof
• Phone: +31302289222
• Email: CSA-RD.phase2@am-pharma.com
• Status: Recruiting
• Phase: Phase 2
• Start date: December 19, 2023
• Completion date: December 31, 2024