Table 1.
CKD stage definition and summary overall and by randomized treatment group per clinical trial*
| |
|
Study CO405 (%) |
Study CO406 (%) |
||||||
|---|---|---|---|---|---|---|---|---|---|
|
CKD stage |
eGFR definition
†
|
PGL q2wks |
PGL q4wks |
Placebo |
Overall |
PGL q2wks |
PGL q4wks |
Placebo |
Overall |
| (n = 43) | (n = 41) | (n = 20) | (n = 104) | (n = 42) | (n = 43) | (n = 23) | (n = 108) | ||
| 1 |
≥90 |
8 (18.6) |
6 (14.6) |
3 (15.0) |
17 (16.3) |
9 (21.4) |
5 (11.6) |
3 (13.0) |
17 (15.7) |
| 2 |
60-89 |
14 (32.6) |
12 (29.3) |
4 (20.0) |
30 (28.8) |
12 (28.6) |
19 (44.2) |
13 (56.5) |
44 (40.7) |
| 3 |
30-59 |
15 (34.9) |
19 (46.3) |
11 (55.0) |
45 (43.3) |
17 (40.5) |
13 (30.2) |
5 (21.7) |
35 (32.4) |
| 4 |
15-29 |
6 (14.0) |
4 (9.8) |
2 (10.0) |
12 (11.5) |
4 (9.5) |
5 (11.6) |
2 (8.7) |
11 (10.2) |
| 5 | <15 (or dialysis) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; PGL, pegloticase; q2wks, every 2 weeks; q4wks, every 4 weeks.
*Based on the intent to treat analysis data set; that is, all randomized patients who received at least one dose of treatment.
†As described by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative.