Table 2.
Results of primaryd, secondarye (as defined in the study protocol) and other efficacy outcomes, N (%)
| Outcome parameter | Placebo (N = 81) | ASP1128 (N = 69) | P-valuea | Risk ratio (90% CI)b | Observational cohort (N = 200) |
|---|---|---|---|---|---|
| AKI-SCr72hd | 17 (21.0) | 17 (24.6) | 0.595 | 1.174 (0.715, 1.927) | 70 (35.0) |
| AKI stage 1 | 16 (19.8) | 11 (15.9) | NDc | ND | 63 (31.5) |
| AKI stage 2 | 0 (0) | 4 (5.8) | NDc | ND | 7 (3.5) |
| AKI stage 3 | 1 (1.2) | 2 (2.9) | NDc | ND | 0 (0) |
| AKI-SCr72h stage 2/3 | 1 (1.2) | 6 (8.7) | 0.031 | 7.043 (1.217, 40.780) | 7 (3.5) |
| AKI-KDIGO72he | 63 (77.8) | 55 (79.7) | 0.773 | 1.025 (0.891, 1.179) | ND |
| AKI-UO72h stage 3 | 16 (19.8) | 14 (20.3) | 0.935 | 1.027 (0.600, 1.760) | ND |
| AKI-SCr72h stage 2/3 and/or AKI-UO72h stage 3 | 16 (19.8) | 16 (23.2) | 0.609 | 1.174 (0.701, 1.965) | ND |
| AKI-SCr7de | 19 (23.5) | 21 (30.4) | 0.335 | 1.297 (0.831, 2.026) | 74 (37.0) |
| AKI-KDIGO7de | 69 (85.2) | 61 (88.4) | 0.563 | 1.038 (0.935, 1.152) | ND |
| MAKE30, all criteriae | 9 (11.1) | 9 (13.0) | 0.717 | 1.174 (0.567, 2.429) | 14 (7.0) |
| All-cause mortality | 0 (0) | 2 (2.9) | 0.123 | ND | 1 (0.5) |
| RRT | 2 (2.5) | 2 (2.9) | 0.871 | 1.174 (0.232, 5.948) | 4 (2.0) |
| Sustained eGFR reduction | 8 (9.9) | 7 (10.1) | 0.956 | 1.027 (0.458, 2.303) | 11 (5.5) |
| MAKE90, all criteriae | 8 (9.9) | 11 (15.9) | 0.266 | 1.614 (0.789, 3.300) | 13 (6.5) |
| All-cause mortality | 2 (2.5) | 3 (4.3) | 0.523 | 1.761 (0.402, 7.713) | 5 (2.5) |
| RRT | 2 (2.5) | 2 (2.9) | 0.871 | 1.174 (0.232, 5.948) | 4 (2.0) |
| Sustained eGFR reduction | 5 (6.2) | 7 (10.1) | 0.371 | 1.643 (0.652, 4.143) | 5 (2.5) |
AKI, acute kidney injury; CI, confidence interval; eGFR, estimated glomerular filtration rate; KDIGO, Kidney Disease Improving Global Outcomes; ND, not done; RRT, renal replacement therapy.
AKI-KDIGO72h, AKI as defined by all KDIGO criteria13 within 72 h after surgery.
AKI-KDIGO7d, AKI as defined by all KDIGO criteria13 within 7 days after surgery.
AKI-SCr7d, AKI as defined by KDIGO based on serum creatinine criteria13 within 7 days after surgery.
AKI-UO72h stage 3, AKI as defined by KDIGO based on urinary output criteria13 severity stage 3 within 72 h after surgery.
MAKE30, major adverse kidney events (all-cause mortality, RRT and/or sustained eGFR reduction [i.e., ≥25% reduction of eGFR-SCr compared with baseline]) within 30 days after surgery.
MAKE90, MAKE within 90 days after surgery.
2-sided P-value (chi-square test).
Risk ratio to placebo (2-sided 90% CI for risk ratio).
Wilcoxon-test distribution severity categories (no AKI, stage 1–3): P = 0.461.
Primary efficacy outcome.
Secondary efficacy outcomes.