Table 2. Thresholds Used for Exclusion of Patients With Kidney Disease in Randomized Clinical Trials of Anticancer Drugs (N = 264 Trials)a.
| Measurement for Kidney Function–Based Exclusiona | No. of Trials (%)b |
|---|---|
| Serum creatinine value | 162 (62) |
| Serum creatinine value relative to ULN | 129 (49) |
| >ULN | 16 (6) |
| >1.25-times ULN | 7 (3) |
| >1.5-times ULN | 93 (35) |
| >2-times ULN | 6 (2) |
| >2.5-times ULN | 6 (2) |
| >5-times ULN | 1 (0.4) |
| Absolute serum creatinine value, mg/dL | 33 (13) |
| >1.5 | 17 (6) |
| >2.0 | 15 (6) |
| >4.0 | 1 (0.4) |
| CrCl, mL/min | 115 (44) |
| <60 | 38 (14) |
| <50 | 44 (17) |
| <45 | 10 (4) |
| <40 | 12 (5) |
| <30 | 11 (4) |
| eGFR, mL/min/1.73 m2 | 14 (5) |
| <60 | 5 (2) |
| <50 | 4 (2) |
| <45 | 1 (0.4) |
| <30 | 4 (2) |
| Proteinuria | 31 (12) |
| Nonspecified renal exclusionc | 41 (16) |
| Multiple exclusion criteria related to kidney functiond | 90 (34) |
Abbreviations: CrCl, creatinine clearance; eGFR, estimated glomerular filtration rate; ULN, upper limit of normal.
a
Some included trials utilized multiple measures of kidney function for exclusion.
b
The percentages reported reflect a denominator of 264 (the total No. of trials with exclusions based on kidney function).
c
An example of nonspecified renal exclusion is “adequate” or “intact” kidney function.
d
An example of multiple exclusion criteria related to kidney function is serum creatinine, CrCl, and proteinuria.