TABLE 3.
Dose definitions (One Pre/Three Post surgery): Arm 2 - 0.02-mg/kg/0.02-mg/kg; Arm 3 - 0.12-mg/kg/0.02-mg/kg; Arm 4 - 0.46-mg/kg/0.02-mg/kg; Arm 5 - 0.46-mg/kg/0.46-mg/kg. KDIGO criteria for diagnosing AKI: Increase in SCr by ≥ 0.3 mg/dl (≥26.5 μmol/L) within 48 h OR Increase in SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days OR Urine volume <0.5 ml/kg/h for 6 h. KDIGO Cr: The full KDIGO criteria minus the Urine volume criterion. sCr >0.3: Increase in sCr by ≥ 0.3 mg/dl (≥26.5 μmol/L) within 48 h sCr >50%: Increase in serum creatinine ‡50% within 7 days. SAE: number of Serious Adverse Events. p-value: Unadjusted p value (two sided) from logistic regression with baseline eGFR as a covariate, comparing the active arm with arm 1 (placebo) (Himmelfarb et al., 2018).
| Analysis of phase 2 | ||||||
|---|---|---|---|---|---|---|
| Arm | 1 | 2 | 3 | 4 | 5 | |
| Placebo | Low Dose | Mid Dose | High Dose | Highest Dose | ||
| Subjects | 113 | 34 | 34 | 116 | 104 | # |
| KDIGO | 77.9 | 79.4 | 76.5 | 75.9 | 74.0 | % |
| p -value | 0.76 | 0.95 | 0.76 | 0.59 | ||
| sCr > 0.3 | 53.1 | 58.8 | 55.9 | 55.2 | 51.9 | % |
| sCr > 50% | 20.4 | 32.4 | 23.5 | 20.7 | 22.1 | % |
| Urine Output | 60.2 | 58.8 | 55.9 | 51.7 | 61.5 | ml/kg/hr |
| KDIGO Cr | 54.9 | 58.8 | 58.8 | 56.0 | 51.9 | % |
| SAE > 1 | 41.7 | 46.7 | 59.6 | 42.0 | 41.0 | % |
| Deaths | 3 | 4 | 5 | 4 | 5 | # |