acute renal failure MedDRA version: 9.1 Level: LLT Classification code 10001041 Term: Acute renal failure
Conditions
Interventions
Product Name: EA-230
Product Code: EA-230
Pharmaceutical Form: Solution for injection
Current Sponsor code: EA-230
Other descriptive name: Peptide 46
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
EBI Anti Sepsis B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients of at least 18 years old 2. Patients who are scheduled to undergo major elective cardiac surgery 3. Patients who are willing to provide informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients undergoing emergency surgery. 2. Severe congestive heart failure EF < 20 %. 3. Congenital heart disease other than corrected atrial septum defect or corrected ventricular septum defect. 4. Patients with a known malignancy or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin 5. Previous organ transplantation. 6. Active or uncontrolled liver disease/hepatitis. 7. Any disease that (a) has required immunosuppressive drugs (including oral or parenteral corticosteroids) during the past 6 months, or that (b) is fairly likely to require administration of such drugs in the post-operative period. Examples of such diseases include COPD, asthma, chronic bronchitis, auto-immune diseases, and so on. However, inhaled or topical steroids are permitted. 8. Patients who are unable themselves to sign the informed consent form, whether because of strokes or cognitive defects (dementia or otherwise). 9. Confirmed HIV-positivity. 10. Active (acute) infectious disease and/or severe chronic infectious disease requiring antibiotic treatment. 11. Active renal disease with a primary cause, e.g. haemolytic uremic syndrome (HUS) or glomerulonephritis requiring immunosuppressive treatment. 12. Patients with kidney failure (calculated GFR [MDRD formula] < 30 mL/min or requiring any kind of dialysis). 13. If female, patients must either: 13a. be post-menopausal for at least 1 year, or 13b. have had a hysterectomy or tubal ligation; If of childbearing potential, patients: Must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin [hCG]) result after surgery. And either: 13c. have maintained her normal menstrual pattern for the 3 months prior to study entry, and have taken hormonal contraceptives for at least 1 month prior to study entry, or 13d. will be using another medically acceptable method of contraception and agree to continue with the same method during the study. 14. Change of ACE and/or AT2 blockers or other medication that may affect renal function within four weeks prior to hospital admission. 15. History of chronic disease which may interfere with the assessment of safety and/or efficacy. 16. Suspected or confirmed intraoperative embolization, e.g. post-aortic cross-clamp cholesterol embolization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of EA-230 on renal function in patients at increased risk of developing renal failure following major cardiac on-pump surgery. ;Secondary Objective: To explore the safety and tolerability of 30 mg/kg and 50 mg/kg EA-230 given i.v. twice daily for three days in patients following major cardiac on-pump surgery. To assess the pharmacokinetics of 30 mg/kg and 50 mg/kg EA-230 given i.v. twice daily in a subset of patients following major cardiac on-pump surgery. ;Primary end point(s): Maximum difference in serum creatinine levels from baseline between EA-230 dose groups and placebo up to 14 days after randomization | — |
Countries
Germany
Outcome results
None listed