Status:
COMPLETED
Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery
Lead Sponsor:
AM-Pharma
Collaborating Sponsors:
FGK Clinical Research GmbH
Conditions:
Open Heart Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- Age ≥18 years
- Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB):
- 1\. 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.
- Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter
- The five most important
Exclusion
- 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
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2025
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT06168799
Start Date
December 19 2023
End Date
December 3 2025
Last Update
December 15 2025
Active Locations (1)
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1
Research site
Munich, Germany