Risk for renal damage following open heart surgery
Conditions
Brief summary
Ratio between the highest value post-surgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and the pre-surgery baseline value for serum creatinine (sCreat)
Detailed description
Incidence rate of adverse events (AEs) and serious AEs through Day 28, Major adverse kidney events (MAKE) 60, defined as died up to and including Day 61, have received or are receiving new renal replacement therapy (RRT) up to and including Day 61, or have a decrease in estimated glomerular filtration rate (eGFR) ≥25% on Day 61 compared to the pre-surgery baseline eGFR reference value
Interventions
DRUGIlofotase alfa
DRUGIlofotase alfa Placebo Drug Product
Sponsors
AM-Pharma B.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio between the highest value post-surgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and the pre-surgery baseline value for serum creatinine (sCreat) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events (AEs) and serious AEs through Day 28, Major adverse kidney events (MAKE) 60, defined as died up to and including Day 61, have received or are receiving new renal replacement therapy (RRT) up to and including Day 61, or have a decrease in estimated glomerular filtration rate (eGFR) ≥25% on Day 61 compared to the pre-surgery baseline eGFR reference value | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed