Table 1.
Criteria for Assessment of Treatment-Emergent Nephrotoxicity
| Protocol-Defined Criteriaa | |
|---|---|
| Baseline Renal Function Category | Serum Cr |
| Normal (serum Cr <1.2 mg/dL) | Doubling of Cr up to >1.2 mg/dL OR ≥50% reduction in CrCl |
| Preexisting dysfunction (serum Cr ≥1.2 mg/dL) | Increases in Cr ≥1 mg/dL OR ≥20% reduction in CrCl OR Initiation of renal replacement therapy |
| KDIGO Criteriab | |
| Stagec | Serum Cr |
| 1 | 1.5–1.9 times baseline OR ≥0.3 mg/dL (≥26.5 µmol/L) increase |
| 2 | 2.0–2.9 times baseline |
| 3 | 3.0 times baseline OR Increase ≥4.0 mg/dL (≥353.6 µmol/L) OR Initiation of renal replacement therapy |
| RIFLE Criteria | |
| Classificationc,d | GFR Criteria |
| Risk | Increased serum Cr × 1.5 OR GFR decrease >25% |
| Injury | Increased serum Cr × 2 OR GFR decrease >50% |
| Failure | Increased serum Cr × 3 OR GFR decrease 75% OR Serum creatinine ≥4 mg/dL (acute rise ≥0.5 mg/dL) |
Abbreviations: AKI, acute kidney injury; Cr, creatinine; GFR, glomerular filtration rate; KDIGO, Kidney Disease: Improving Global Outcomes; RIFLE, Risk, Injury, Failure, Loss, and End-stage Kidney Disease.
aCriteria assessed a priori.
bCriteria assessed retrospectively.
cIf a participant met criteria for >1 AKI stage/classification, the participant was included only once, in the “worst-case” stage/classification.
dLoss of kidney function (>4 weeks) and end-stage kidney disease (>3 months) classifications were not included due to the study duration being less than the defined timelines.