Table 3.
Study ID | Tacrolimus formulation/starting regimen | Target tacrolimus trough concentration (ng/mL) | Immunosuppressive regimen | |||
---|---|---|---|---|---|---|
ER-Tac | IR-Tac | CS | Antiproliferative agents | Induction therapy and conditioning treatment | ||
Crespo et al. (2009) [26] |
MR-4; 0.2 mg/kg OD from Day 1 post-KT |
Innovator; 0.1 mg/kg BID from Day 1 post-KT |
N/A | ✓ | MPA | Anti-CD25 monoclonal antibodies |
Andrés et al. (2010) [27] | MR-4 | Innovator |
Immediate post-KT: 9–12, Maintenance phase: 5–10 |
✓ | MPA | N/A |
Jelassi et al. (2011) [28] |
MR-4; 0.2 mg/kg OD immediately post-KT (except 1 KTR received 0.4 mg/kg/d) |
Innovator; 0.1–0.3 mg/kg/day immediately post-KT |
5–15 | ✓ | MPA | IVIG |
Fanous et al. (2013) [29] |
MR-4; 0.1 mg/kg/day started within 6 h of engraftment |
Innovator; 0.1 mg/kg/day started within 6 h of engraftment |
5–10 | ✓ | MMF |
ATG or basiliximab, ± IVIG |
Ishida et al. (2013) [30] |
MR-4; 0.15–0.2 mg/kg OD started 7 days prior to KT in ABOc KTRs or 14 days prior to KT in ABOi KTRs |
Innovator;; 0.15–0.2 mg/kg/day BI.D started 7 days prior to KT in ABOc KTRs or 14 days prior to KT in ABOi KTRs |
First month: 9–12, Month 1–3: 6–8, Thereafter: 5–7 |
✓ | MMF |
Basiliximab for ABOc KT Rituximab and DFPP for ABOi KT |
Masutani et al. (2014) [31] | MR-4 | Innovator | N/A | ✓ | MMF |
Basiliximab for ABOc KT Rituximab and DFPP for ABOi KT, pre-sensitized patients with positive flow cytometric PRA |
Fan et al. (2017) [32] |
MR-4; 0.1–0.15 mg/kg OD from Day 0 before surgery |
Innovator; 0.1–0.15 mg/kg/day given B.I.D. from Day 0 before surgery |
First month: 8–12 | ✓ | MMF | Preoperative ATG |
Niioka et al. (2017) [33] |
MR-4; 0.2 mg/kg OD started 2 days prior to KTa, or 7 days prior to KT in ABOi KTRs |
Innovator; 0.1 mg/kg BID started 2 days prior to KTa, or 7 days prior to KT in ABOi KTRs |
First week: 15–20, Second week: 12, Third week: 10, Thereafter: < 8 |
✓ | MMFb |
Basiliximab for ABOc KT Rituximab or splenectomy for ABOi KT |
Hage et al. (2019) [34] | MR-4 | Innovator | N/A | ✓ | MPAc | T-cell depleting agent/basiliximab/no induction therapy: ER-Tac, 4.9/53.6/41.5%; IR-Tac, 9.5/69/21.4% |
Ho et al. (2019) [35] |
MR-4; started within 10 days of transplantationd |
Either generic or branded formulations | 6–10 | ✓ | N/A | Basiliximab or alemtuzumab or neither |
ABOc ABO blood group compatible, ABOi ABO blood group incompatible, ATG anti-thymocyte globulin, BID twice daily, CS corticosteroid, DFPP double filtration plasmapheresis, ER-Tac extended-release tacrolimus, IR-Tac immediate-release tacrolimus, IVIG intravenous immunoglobulin, KT, kidney transplantation, KTRs, kidney transplant recipients, MMF mycophenolate mofetil, MPA mycophenolic acid, MR-4 MR-4 tacrolimus formulation, N/A no available information, OD once daily, PRA panel reactive antibody
aA 24-h continuous IV infusion of 0.05 mg/kg/day of tacrolimus was administered for the first 3 days after surgery. On the fourth postoperative day, intravenous administration was discontinued, and the same dose as initial oral dose was administered orally
bFourteen of 80 KTRs who were given ER-Tac were treated with everolimus
cA proportion of patients were converted from mycophenolic acid to mammalian target of rapamycin inhibitor during the follow-up period
dIR-Tac was started if tacrolimus therapy was initiated during the initial hospital stay and subsequently, were switched to ER-Tac upon hospital discharge. If the first dose of tacrolimus therapy was initiated after hospital discharge, KTRs were stared and maintained on ER-Tac. The median time between KT and initiation of ER-Tac was 1.5 days [interquartile range (IQR), 1.3–3.0 days]. The median time of receiving ER-Tac was 490 days (IQR, 111–632 days)