Trough 10–12 ng/mL for 6 months and 5–10 ng/mL afterward
Wound infection happened in 6.5% of SRL-MMF-Pred as compared to 3.3% in CsA-MMF-Pred lymphocele was reported in 9.7% of SRL-MMF-Pred and 3.3% of CsA-MMF-Pred
Wound complication occurred in 17% of the subjects in the TAC sparing group and in 7% of the subjects in the TAC-free group (=NS). The incidence of lymphocele or fluid collections was 20% in the CI-sparing and 10% in the CI-free group (=NS)
Loading dose was given before December 1, 2002 No loading dose was given after December 1, 2002
C0 = 7 ng/mlc0 = 8–12 ng/mL
Wound healing complications were 8%, 18%, and 25% in CsA-MMF, low-dose SRL, and high-dose SRL, P = 0.02 Wound healing complications reduced to 5%, 11%, and 20% in CsA-MMF, low-dose SRL, and high-dose SRL, P = 0.3 after stopping loading dose after December 1, 2002
Yes Group 1: full dose of 10 mg/day orally (single morning dose) for 3 days and then maintained at 5 mg/day Group 2: a single oral morning dose of 10 mg/day
SRL (C0, 6–12 ng/mL) SRL (C0, 10–15 ng/mL)
There were 7 wound complications, 4 lymphoceles, and 1 urinary fistula in TAC sparing regimen. There were 11 wound complications, 7 lymphoceles, and 2 urinary fistulas in TAC-free regimen. Surgical complications between two groups were not significant ( = 0.127)
Yes 1-SRL-TAC-Pred: loading dose 1.5 mg, then maintenance 0.5 mg per day 2-SRL-TAC-Pred loading dose 6 mg, then 2 mg per day
Median C0 levels in the TAC‐SRL0.5 mg group were 0.95 ng/mL during week 1, 1.46 ng/mL at month 3, and 1.43 ng/mL from 4 to 6 months Median C0 level TAC-SRL 2 mg group was 2.71 ng/mL during week 1, 4.57 ng/mL at month 3, and 4.75 ng/mL between months 4 and 6
Low SRL group has lymphocele in 4.3% as compared to 8.6% in high SRL group. = 0.022
1-standard-dose CsA-MMF-Pred 2-low-dose CsA-MMF- Pred 3-low-dose TAC-MMF-Pred 4-low-dose SRL
Yes (oral SRL at a dose of 9 mg per day for 3 days and 3 mg per day to aim for target level C0 = 4 to 8 ng/mLl)
C0 = 4 to 8 ng/mL
The incidence of lymphocele was double in low-dose SRL as compared to other groups which was high ( < 0.001). The incidence of delayed wound healing was also significantly high in low-dose SRL as compared to other = 0.006
Yes (loading dose 15 mg for 2 days, then 10 mg for 1 day)
C0 = 10–15 ng/mL
-Hernia/evisceration occurred in 9.9% vs. 0% in SRL group and CsA group comparatively (=0.006) Lymphocele occurred in 11.3 and 5.4%, respectively, between two groups but were not significant
Yes (SRL 10 mg loading dose for first two days and then 5 mg once daily were given in both groups)
C0 = 10–25 ng/m L
Delayed wound healing between two groups (SRL-TAC-Pred 13.4% vs. SRL-CsA-Pred 16.5%) was not significant Lymphocele occurred significantly more in SRL-CsA-Pred (27.2% vs. 18.8%) in SRL-TAC-Pred group (P0.043)
C0 = 10–20 ng/mL for 3 months and then 8–15 ng/mL afterward
Impaired wound healing occurred in 3.2% of SRL group as compared to 1.6% in CsA group Lymphocele occurred in 14.3% of SRL group as compared to 3.1% in CsA group = 0.03
Wound healing complications occurred in 11%, 11%, 9%, and 17%, respectively, in each group and was significantly higher across the group (=0.006) Lymphocele occurred in 7%, 6.8%, 9%, and 15.8%, respectively and = <0.001 across groups for lymphocele formation
1-SRL-TAC for 3 months-Pred 2-srl-MMF-Pred 2-MMF-TAC-Pred
Yes (loading dose of 15 mg given to both SRL groups)
C0 = 8–15 ng/mL for 3 months and then 10–20 ng/mL afterward in SRL-TAC-MMF group C0 = 10–15 ng/mL for 3 months, then 8–15 ng/mL for 3–6 months and then 5–15 ng/mL afterward
Delayed wound healing occurred in 16.4% in SRL-TAC-Pred, 23% in SRL-MMF-Pred, and 5.8% in MMF-TAC-Pred. < 0.01 for delayed wound healing for SRL-TAC-Pred as compared to MMF-TAC-Pred Lymphocele occurred in 16.4% in SRL-TAC-Pred, 18.4% in SRL-MMF-Pred, and 8.6% MMF-TAC-Pred
Yes (initially 10 to 15 mg SRL oral loading dose within 2 days, 4 to 8 mg daily) Amendment was done and SRL group received two 15 mg oral loading doses within for 2 days followed by 10 mg daily to achieve C0 = 10.0 ng/mL or more
C0 = day 1 to week 13, 10–15 ng/mL; weeks 14–26, 8–12 ng/mL; weeks 27–104, 5–12 ng/mL. After amendment C0 = day 1 to week 26, 10–15 ng/mL; weeks 27–104, 8–15 ng/mL.
15.2% of SRL and 8.2% of CSA had wound healing complication, = 0.033
2 mg of SRL was given within 24 hours of transplant, C0 = 3–5 ng/mL.
SRL group has 10.5% wound healing complications as compared to 2.7% in MMF group, but P value = 0.10 was not significant Risk of lymphocele was 0% in SRL group and 1.3% in MMF (P = 0.10)
