Table 2.
Withdrawal and Study Drug Discontinuation
| Anakinra (N=38) | Placebo (N=42) | P-value | |
|---|---|---|---|
|
| |||
| Withdrawal from trial, No. (%) | 8 (21.1) | 8 (19.0) | 0.7 |
| Kidney transplantation | 3 | 3 | |
| Transfer to non-participating dialysis unit | 1 | 0 | |
| Participant decision | 1 | 0 | |
| Investigator decision | 0 | 1 | |
| Death | 2 | 4 | |
| Other1 | 1 | 0 | |
|
| |||
| Study drug permanent discontinuation, No. (%) | 12 (31.6) | 11 (26.2) | 0.6 |
| Infection | 1 | 1 | |
| Central venous dialysis catheter | 0 | 1 | |
| Allergy | 1 | 0 | |
| Cytopenia | 1 | 0 | |
| Kidney transplantation | 1 | 2 | |
| Initiation of prohibited medication | 0 | 1 | |
| Transfer to non-participating dialysis unit | 2 | 0 | |
| Participant decision | 5 | 3 | |
| Investigator decision | 1 | 1 | |
| Other | 0 | 2 | |
|
| |||
| Study drug temporary discontinuation, No (%) | 13 (34.2) | 12 (28.6) | 0.6 |
|
| |||
| % Study drug administration, mean (SD) | |||
| % of target dose2 | 71.9 (30.7) | 75.5 (31.8) | 0.6 |
| % of expected dose3 | 94.6 (10.8) | 94.9 (8.4) | 0.9 |
1
One participant was withdrawn at Week 4 of previously unrecognized pre-randomization neutrophil count <2,500 cells/mm3
2
Target dose is the total dose that would be administered if a participant remained on study drug for the full 24 weeks and is an indication of exposure to study drug
3
Expected dose is the total dose that should be administered while a participant is being followed and while study drug has not been temporarily or permanently discontinued and is an indication of protocol fidelity