Sepsis associated acute kidney injury
Conditions
Brief summary
The weighted average of area under the time-corrected endogenous creatinine clearance curve from Day 1 to Day 8 (AUC1-8).
Detailed description
Composite endpoint of major adverse kidney events (MAKE) including death, use of RRT and ≥25% reduction from reference in eGFR at Day 90, The weighted average of area under the time-corrected endogenous serum creatinine and endogenous serum cystatin C curve from Day1 to Day14 and Day1 to Day30 The weighted average of area under the time-corrected endogenous creatinine clearance curve from Day5 to Day14 (AUC5-14). Any use of RRT during the study RRT dependency at Day90 Days alive and free of RRT at Day90 Proportion of participants with eGFR decline ≥25% from reference at Day90 Change of KDIGO AKI stage from baseline at Day14., Change of sequential organ failure assessment (SOFA) score from baseline to Day 30, Adverse events and serious adverse events
Interventions
DRUGTIN816
DRUGSterile 0.9% sodium chloride solution for infusion will be administered as placebo to participants randomized to the placebo treatment. The solution is ready to use in a 100mL infusion bag of 0.9% sodium chloride solution
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The weighted average of area under the time-corrected endogenous creatinine clearance curve from Day 1 to Day 8 (AUC1-8). | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite endpoint of major adverse kidney events (MAKE) including death, use of RRT and ≥25% reduction from reference in eGFR at Day 90, The weighted average of area under the time-corrected endogenous serum creatinine and endogenous serum cystatin C curve from Day1 to Day14 and Day1 to Day30 The weighted average of area under the time-corrected endogenous creatinine clearance curve from Day5 to Day14 (AUC5-14). Any use of RRT during the study RRT dependency at Day90 Days alive and free of RRT at Day90 Proportion of participants with eGFR decline ≥25% from reference at Day90 Change of KDIGO AKI stage from baseline at Day14., Change of sequential organ failure assessment (SOFA) score from baseline to Day 30, Adverse events and serious adverse events | — |
Countries
Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Spain
Outcome results
None listed