Sepsis-associated acute kidney injury (AKI)
Conditions
Brief summary
Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl)
Detailed description
Days alive and free of KRT, Days alive and free of modified KDIGO AKI Stage 2 or 3, AUC: Serum creatinine, Serum cystatin C, mGFR, Cmax/Cbaseline: Serum creatinine, Serum cystatin C, AUC: Plasma and urine IL-18, Plasma and urine IL-6, Plasma concentrations of AZD4144, Occurrence of any of the following MAKE30 components: (a) Decrease from pre-AKI reference eGFR of ≥ 25% (b) Initiation of KRT at any time (c) Death from any cause, Days alive and free of mechanical ventilation, Days alive and outside of the ICU, Rehospitalisation, Days alive and free of hospitalisation, Days alive and free of vasopressor and/or inotrope use, AUC mSOFA score
Interventions
DRUGAZD4144
DRUGPlacebo for AZD4144
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl) | — |
Secondary
| Measure | Time frame |
|---|---|
| Days alive and free of KRT, Days alive and free of modified KDIGO AKI Stage 2 or 3, AUC: Serum creatinine, Serum cystatin C, mGFR, Cmax/Cbaseline: Serum creatinine, Serum cystatin C, AUC: Plasma and urine IL-18, Plasma and urine IL-6, Plasma concentrations of AZD4144, Occurrence of any of the following MAKE30 components: (a) Decrease from pre-AKI reference eGFR of ≥ 25% (b) Initiation of KRT at any time (c) Death from any cause, Days alive and free of mechanical ventilation, Days alive and outside of the ICU, Rehospitalisation, Days alive and free of hospitalisation, Days alive and free of vasopressor and/or inotrope use, AUC mSOFA score | — |
Countries
Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Spain
Outcome results
None listed