Table 1.
The characteristics of kidney transplant recipients treated with two different tacrolimus formulations.
| Study Group n = 65 |
Prograf n = 30 |
Advagraf n = 35 |
p | |
|---|---|---|---|---|
| Clinical characteristics | ||||
| Age (years) | 46.6 (43.9–49.4) | 44.8 (40.9–48.9) | 48.2 (44.3–52.2) | 0.21 |
| Gender (M/F) | 38/27 | 17/13 | 21/14 | 0.79 |
| BMI (kg/m2) | 26.4 (25.3–27.5) | 26.1 (24.6–27.5) | 26.7 (25.0–28.3) | 0.58 |
| Dialysis vintage (months) * | 24 (13–34) | 24 (13–36) | 23 (13–31) | 0.68 ** |
| Time post transplantation (months) * | 30 (27–86) | 28 (25–31) | 60 (29–93) | <0.001 ** |
| eGFR (ml/min/1.73 m2) | 58.2 (52.8–63.5) | 59.5 (52.1–67.0) | 57.0 (49.0–65.0) | 0.64 |
| MMF dose (mg/day) * | 1000 (750–1000) | 1000 (1000–1000) | 1000 (500–1000) | 0.26 ** |
| Steroid use (n (%)) | 45 (69.2) | 20 (66.7) | 25 (71.4) | 0.68 |
| IMT (mm)* | 0.6 (0.6–0.7) | 0.6 (0.6–0.7) | 0.6 (0.6–0.8) | 0.50 ** |
| Calcified plaques (n (%)) | 28 (43.1) | 12 (40) | 16 (46) | 0.64 |
| Tacrolimus exposure | ||||
| Daily tacrolimus dose (mg) * | 4.0 (3.0–4.5) | 3.8 (2.5–4.5) | 4.0 (3.0–4.5) | 0.49 ** |
| Tacrolimus dose/kg of body weight (mg/kg) * | 0.047 (0.036–0.062) | 0.047 (0.034–0.061) | 0.047 (0.039–0.068) | 0.44 ** |
| Tacrolimus trough level (ng/mL) * | 6.2 (5.4–7.4) | 6.3 (5.8–7.8) | 5.8 (5.2–7.4) | <0.01 ** |
| Tacrolimus AUC (ng.h/mL) | 104.6 (96.0–113.3) | 105.8 (87.0–124.7) | 104.1 (93.7–114.5) | 0.44 |
| Estimated 12-month tacrolimus exposure (ng.year/mL) | 2375 (2251–2499) | 2483 (2275–2692) | 2282 (2133–2430) | <0.01 |
| Estimated 12-month tacrolimus exposure calculated per kg of body weight | 31.7 (29.5–33.9) | 32.4 (29.3–35.5) | 31.1 (28.0–34.3) | 0.18 |
| Laboratory parameters | ||||
| hsCRP (mg/l) * | 2.0 (1.2–4.3) | 1.9 (1.2–4.3) | 2.3 (1.2–5.7) | 0.22 ** |
| IL-6 (pg/mL) * | 2.1 (1.6–2.7) | 2.0 (1.6–2.5) | 2.2 (1.6–2.7) | 0.38 ** |
| TNF-α (pg/mL) * | 1.8 (1.3–2.4) | 1.6 (1.3–2.0) | 1.8 (1.4–2.4) | 0.11 ** |
| ET-1 (pg/mL) | 20.1 (17.9–22.3) | 19.5 (16.7–22.4) | 20.6 (17.2–24.0) | 0.63 |
| ADMA (µmol/l) | 0.92 (0.83–1.00) | 1.03 (0.89–1.17) | 0.82 (0.71 -0.93) | 0.02 |
| BDNF (pg/mL) * | 1760 (1120–5348) | 1620 (1120–5348) | 2647 (1256–4980) | 0.67 ** |
Data presented as means with 95% Confidence Interval, except * medians with interquartile range. Statistics: Student t test or χ2 test, except ** U Mann–Whitney test, for comparison between the Prograf and Advagraf subgroups. BMI, body mass index; eGFR, estimated glomerular filtration rate according to MDRD formula; IMT, carotid artery intima-media thickness; AUC, area under the curve for tacrolimus; hsCRP, high sensitive C-reactive protein; IL-6, interleukin-6; TNF-α, tumor necrosis factor α; ET-1, endothelin 1; ADMA, asymmetric dimethylarginine; BDNF, brain-derived neurotrophic factor.