29 May 2020 : Original article
Outcomes with Tacrolimus-Based Immunosuppression After Kidney Transplantation from Standard- and Extended-Criteria Donors – A Post Hoc Analysis of the Prospective OSAKA Study
Laetitia Albano BDE 1, Bernard Banas BDE 2, Frank Lehner BDE 3, Maciej Glyda BDE 4,5, Ondrej Viklicky BDE 6, Stefan Schleibner CDE 7, Malcolm Brown ADE 8, Nassim Kamar BDE 9*DOI: 10.12659/AOT.920041
Ann Transplant 2020; 25:e920041
Supplementary Table 3 Incidence of treatment-emergent AEs stratified by treatment arm and donor group (FAS).
| AEs, n (%) | Arm 1Immediate-release tacrolimus0.2 mg/kg/day | Arm 2Prolonged-release tacrolimus0.2 mg/kg/day | Arm 3Prolonged-release tacrolimus0.3 mg/kg/day | Arm 4Prolonged-release tacrolimus0.2 mg/kg/day +basiliximab | Overall | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 293/311 (94.2) | 289/309 (93.5) | 295/307 (96.1) | 270/287 (94.1) | 1147/1214 (94.5) | |||||||||
| ECDn=154 | SCDn=155 | ECDn=155 | SCDn=147 | ECDn=153 | SCDn=151 | ECDn=158 | SCDn=125 | ECD, Arms1–4p value | SCD, Arms1–4p value | ECDn=620 | SCDn=578 | p value | |
| Anemia | 63 (40.9) | 39 (25.2) | 58 (37.4) | 45 (30.6) | 59 (38.6) | 39 (25.8) | 64 (40.5) | 29 (23.2) | 0.9129 | 0.5416 | 244 (39.4) | 152 (26.3) | |
| Urinary tract infection | 47 (30.5) | 38 (24.5) | 35 (22.6) | 35 (23.8) | 58 (37.9) | 38 (25.2) | 46 (29.1) | 33 (26.4) | 0.0336 | 0.9671 | 186 (30.0) | 144 (24.9) | 0.0523 |
| Diarrhea | 42 (27.3) | 28 (18.1) | 42 (27.1) | 27 (18.4) | 48 (31.4) | 29 (19.2) | 44 (27.8) | 24 (19.2) | 0.8220 | 0.9921 | 176 (28.4) | 108 (18.7) | |
| Delayed graft function | 33 (21.4) | 12 (7.7) | 30 (19.4) | 19 (12.9) | 19 (12.4) | 16 (10.6) | 39 (24.7) | 15 (12.0) | 0.0470 | 0.4940 | 121 (19.5) | 62 (10.7) | |
| Edema | 33 (21.4) | 21 (13.5) | 30 (19.4) | 23 (15.6) | 28 (18.3) | 15 (9.9) | 26 (16.5) | 10 (8.0) | 0.7253 | 0.1930 | 117 (18.9) | 69 (11.9) | 0.0010 |
| Creatinine elevation | 23 (14.9) | 24 (15.5) | 23 (14.8) | 22 (15.0) | 24 (15.7) | 21 (13.9) | 20 (12.7) | 17 (13.6) | 0.8865 | 0.2702 | 90 (14.5) | 84 (14.5) | >0.9999 |
| Hyperglycemia | 17 (11.0) | 20 (12.9) | 23 (14.8) | 18 (12.2) | 21 (13.7) | 24 (15.9) | 23 (14.6) | 15 (12.0) | 0.7555 | 0.7469 | 84 (13.5) | 77 (13.3) | 0.9326 |
| Hyperlipidemia | 15 (9.7) | 20 (12.9) | 14 (9.0) | 8 (5.4) | 12 (7.8) | 10 (6.6) | 4 (2.5) | 11 (8.8) | 0.0587 | 0.0960 | 45 (7.3) | 49 (8.5) | 0.4531 |
| Renal impairment | 24 (15.6) | 14 (9.0) | 23 (14.8) | 9 (6.1) | 29 (19.0) | 20 (13.2) | 22 (13.9) | 12 (9.6) | 0.6426 | 0.2170 | 98 (15.8) | 55 (9.5) | 0.0013 |
| Tremor | 19 (12.3) | 18 (11.6) | 21 (13.5) | 16 (10.9) | 14 (9.2) | 18 (11.9) | 19 (12.0) | 9 (7.2) | 0.6730 | 0.5746 | 73 (11.8) | 61 (10.6) | 0.5219 |
| CMV infection | 16 (10.4) | 10 (6.5) | 24 (15.5) | 4 (2.7) | 25 (16.3) | 9 (6.0) | 17 (10.8) | 5 (4.0) | 0.2727 | 0.4061 | 82 (13.2) | 28 (4.8) | |
| Hypertension | 24 (15.6) | 21 (13.5) | 26 (16.8) | 20 (13.6) | 16 (10.5) | 18 (11.9) | 27 (17.1) | 10 (8.0) | 0.3286 | 0.4549 | 93 (15.0) | 69 (11.9) | 0.1285 |
| Toxic nephropathy | 5 (3.2) | 7 (4.5) | 6 (3.9) | 4 (2.7) | 12 (7.8) | 5 (3.3) | 18 (11.4) | 6 (4.8) | 0.0121 | 0.7712 | 41 (6.6) | 22 (3.8) | 0.0375 |
| PTDM | 29 (22.8)* | 23 (16.0)† | 19 (15.1)‡ | 11 (8.1)§ | 22 (17.2)@ | 22 (15.9)¶ | 19 (14.4)** | 11 (10.1)†† | 0.2698 | 0.1178 | 89 (17.3)‡‡ | 67 (12.7)§§ | 0.0455 |
| Ongoing insulin therapy | 10 (7.8)* | 14 (9.7)† | 13 (10.3)‡ | 8 (5.9)§ | 18 (14.1)@ | 9 (6.5)¶ | 7 (5.3)** | 4 (3.7)†† | 0.0951 | 0.2765 | 48 (9.4)‡‡ | 35 (6.7)§§ | 0.1108 |
| * n=127; † n=144; ‡ n=126; § n=135; @ n=128; ¶ n=138; ** n=132; †† n=109; ‡‡ n=513, §§ n=526; data are n (%), unless otherwise specified; delayed graft function was defined as dialysis for more than one day within the first week post transplantation; toxic nephropathy was reported as an AE by the investigators. P values across treatment arms within ECD and SCD groups were calculated with the chi-squared test. P values for ECD SCD groups were calculated with Fisher’s exact test. AE – adverse event; CMV – cytomegalovirus; ECD – extended-criteria donors; FAS – full-analysis set; PTDM – post transplantation diabetes mellitus; SCD – standard-criteria donors. | |||||||||||||