Acute kidney injury
Conditions
Brief summary
Ratio of the highest serum creatinine value (up to and including Study Day 6) versus baseline
Detailed description
Safety based on vital signs, physical examination, ECGs, laboratory assessments and collection of AEs assessed from baseline until the end of the study visit, AKI stages 1, 2 and 3 as defined by modified AKI Network (AKIN) criteria for serum creatinine, Anti-drug antibodies against TIN816, Occurrence of major adverse kidney events at day 30 (MAKE30) and day 90 (MAKE90) Occurrence of individual components of the MAKE criteria at Days 30 or 90.
Interventions
DRUGTIN816
DRUGPlacebo to TIN816 70mg powder for solution for injection or infusion
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of the highest serum creatinine value (up to and including Study Day 6) versus baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety based on vital signs, physical examination, ECGs, laboratory assessments and collection of AEs assessed from baseline until the end of the study visit, AKI stages 1, 2 and 3 as defined by modified AKI Network (AKIN) criteria for serum creatinine, Anti-drug antibodies against TIN816, Occurrence of major adverse kidney events at day 30 (MAKE30) and day 90 (MAKE90) Occurrence of individual components of the MAKE criteria at Days 30 or 90. | — |
Countries
Belgium, Czechia, Estonia, France, Germany, Hungary, Spain
Outcome results
None listed