Long-term outcome of ketoconazole and tacrolimus co-administration in kidney transplant patients

Table 1 Demographic characteristics of transplant patients between Group 1 (with ketoconazole) and Group 2 (without ketoconazole)

	Group 1(n = 199)	Group 2(n = 149)	P value
Age, mean ± SD (yr)	47.2 ± 13.2	48.8 ± 14.4	0.21
Gender (%)
Male	56	61	0.47
Female	44	39
Race (%)
Black	64	55	0.19
Non-black	36	45
BMI (kg/m2)	28.3 ± 5.4	27.4 ± 5.7	0.34
Peak PRA (%)	15.5 ± 25.3	13.8 ± 27.0	0.27
HLA mismatch	4.1 ± 1.4	3.9 ± 1.6	0.52
Causes of ESRD (%)			0.75
Diabetes	25	31
Hypertension	38	35
Nephritis	19	15
PCKD	8	6
Others	10	13
Induction (%)	55	51	0.51
Donors (%)			0.63
Living	26	29
Deceased	74	71
CIT (h)	17.8 ± 7.2	18.5 ± 6.4	0.24

SD: Standard deviation; BMI: Body mass index; PRA: Panel reactive antibodies; HLA: Human leukocyte antigen; ESRD: End stage renal disease; PCKD: Polycystic kidney disease.

Table 2 Tacrolimus dose, trough level and kidney function in the two groups

	1 wk	1 mo	2 mo	1 yr	3 yr	5 yr
Tacrolimus dose (mg/d)
Group 1	10.9 ± 5.6	7.5 ± 4.8	6.0 ± 3.6	5.6 ± 3.8	5.3 ± 3.1	4.9 ± 2.8
Group 2	8.6 ± 4.1	8.3 ± 3.7	8.1 ± 3.2	7.8 ± 3.0	7.0 ± 2.2	6.2 ± 2.5
P value	0.004	0.03	< 0.001	< 0.001	< 0.001	< 0.001
Tacrolimus trough level (× 10 mg/L)
Group 1	11.3 ± 2.1	9.7 ± 1.9	9.3 ± 1.7	8.6 ± 2.1	6.4 ± 1.9	5.3 ± 1.4
Group 2	10.7 ± 1.8	10.2 ± 2.0	9.5 ± 1.6	9.0 ± 1.8	5.8 ± 1.7	4.8 ± 1.5
Serum Cr (× 10 mg/L)
Group 1	2.2 ± 1.3	1.7 ± 1.1	1.5 ± 0.9	1.6 ± 1.2	1.6 ± 0.8	1.7 ± 0.9
Group 2	1.9 ± 1.1	1.7 ± 0.9	1.6 ± 0.7	1.5 ± 0.8	1.5 ± 0.7	1.6 ± 0.8

Table 3 Post transplant events and causes of graft loss and patient death

	Group 1(n = 199)	Group 2(n = 149)	P value
Posttransplant events, n (%)
Delayed graft function	56 (28)	39 (26)	0.77
Acute rejection	68 (34)	27 (18)	0.01
Type of rejection			0.49
Cellular rejection	49	17
Antibody rejection	14	6
Both rejections	5	4
CNI toxicity	8 (4)	15 (10)	0.09
Infectious diseases	63 (32)	54 (36)	0.37
Type of infection			0.67
CMV	32	22
BKV	14	13
HSV	5	6
Bacteria	7	10
Fungus	5	3
Total graft loss, n (%)	52 (26)	35 (23)	0.57
Causes of graft loss			0.88
DWFG	22	16
CAN	17	10
Rejection	9	5
Infection	2	3
Others	2	1
Total patient death, n (%)	27 (14)	18 (12)	0.68
Causes of death			0.88
CVD	14	10
Infections	6	5
Malignancy	2	2
Others	3	1

CNI: Calcineurin inhibitor; CMV: Cytomegalovirus; HSV: Herpes simplex virus; CVD: Cerebrovascular disease.

Table 4 Multivariable analysis of risk factors for acute rejection

	Hazard ratio	95%CI	P value
Race (black vs non-black )	2.68	1.67-6.73	0.032
Donor (living vs deceased)	0.32	0.11-0.94	0.038
Ketoconazole (yes vs no)	2.33	1.33-4.07	0.003
Delayed graft function (yes vs no)	2.14	1.22-3.73	0.008
Infection (yes vs no)	1.89	1.04-3.48	0.038
Tacrolimus dose (mg/d) in 2nd month	0.89	0.75-0.96	0.041