Table 6.
Clinical and therapeutic drug monitoring data in patients with and without interstitial fibrosis and tubular atrophy progression between biopsies.
| Variable | No Progression | IFTA Progression | p-Value |
|---|---|---|---|
| (n = 50) | (n = 35) | ||
| Donor age (years) | 54 ± 16 | 50 ± 13 | 0.285 |
| Donor type (DD/LD) | 43 (86%)/7 (14%) | 29 (82.8%)/6 (17.2%) | 0.382 |
| Recipient age (years) | 54 ± 13 | 50 ± 14 | 0.184 |
| 1st transplant/re-transplant | 45 (90%)/5 (10%) | 31 (88.6%)/4 (11.4%) | 0.551 |
| HLA-DR mismatch | 1.0 ± 0.7 | 0.9 ± 0.7 | 0.856 |
| Cold ischemia time (hours) | 15 ± 7 | 14 ± 8 | 0.850 |
| Induction (IL2-RA/ATG) | 29 (58%)/21 (42%) | 22 (62.9%)/13 (37.1%) | 0.558 |
| DGF (no/yes) | 48 (96%)/2 (4%) | 32 (91.4%)/3 (8.6%) | 0.399 |
| T-cell mediated rejection (no/yes) | 47 (94%)/3 (6%) | 34 (97%)/1 (3%) | 0.640 |
| Time of biopsy (months) | 17.7 ± 4.1 | 16.6 ± 2.7 | 0.156 |
| Serum creatinine (mg/dL) | 1.25 ± 0.29 | 1.29 ± 0.27 | 0.582 |
| eGFR (mL/min/1.73 sqm) | 64 ± 18 | 63 ± 16 | 0.881 |
| Urine P/C ratio (mg/g) | 310 ± 340 | 350 ± 425 | 0.622 |
| Tacrolimus dose 1st bx (mg/day) | 5.8 ± 3.8 | 7.4 ± 3.8 | 0.058 |
| Tacrolimus dose 2nd bx (mg/day) | 4.3 ± 2.9 | 5.8 ± 3.2 | 0.023 |
| MMF dose (mg/kg/day) | 12.9 ± 3.2 | 12.7 ± 3.4 | 0.836 |
| TAC-C0 1st biopsy (ng/mL) | 9.8 ± 2.7 | 9.4 ± 1.9 | 0.515 |
| TAC-C0 2nd biopsy (ng/mL) | 8.1 ± 1.7 | 9.1 ± 2.8 | 0.053 |
| CV of TAC-C0 until first biopsy (%) | 32 ± 13 | 30 ± 13 | 0.503 |
| CV of TAC-C0 between biopsies (%) | 21 ± 18 | 18 ± 7 | 0.305 |
| Time in TR between biopsies (%) | 73 ± 25 | 67 ± 27 | 0.353 |
| Time above TR between biopsies (%) | 22 ± 25 | 29 ± 29 | 0.318 |
| Time below TR between biopsies (%) | 5 ± 12 | 4 ± 9 | 0.798 |
| Mean C/D (ng/mL/mg) | 2.3 ± 1.3 | 1.7 ± 0.7 | 0.019 |
DD, deceased donor; LD, living donor; DGF, delayed graft function; eGFR, estimated glomerular filtration rate by MDRD-4 formula; urine P/C ratio, urine protein creatinine ratio; TAC-C0, tacrolimus trough levels; CV of TAC-C0, coefficient of variability of tacrolimus trough levels; TR, percentage of time in/above/below the therapeutic range; C/D, concentration dose ratio of tacrolimus.