Impact of cytochrome P450 3A5 expression on clinical outcomes in renal transplant recipients receiving tacrolimus-based immunosuppression

Table 1 Clinical characteristics of renal transplant patients between expressor and non-expressors

Variable	Expressors (n = 35)		Non-expressors (n = 60)		P value
	n	%	n	%
Gender
Male	27	77.1	48	80	0.7431
Female	8	22.9	12	20
Age group
10-30 years	13	37.1	18	30.0	0.7399
31-50 years	17	48.6	31	51.7
> 50 years	5	14.3	11	18.3
Comorbidities
Diabetes	6	17.1	10	16.7	0.9525
Hypertension	21	60.0	30	50.0	0.3483
Donor
Father	2	5.7	3	5.0	0.2172
Mother	8	22.9	16	26.7
Wife	3	8.6	4	6.7
Other	22	62.9	37	61.7
Kidney
Live	30	85.7	53	88.3	0.7123
Cadaveric	5	14.3	7	11.7

Table 2 Association of cytochrome P450 3A5 polymorphism with tacrolimus doses in expressors and non-expressors

Timeline	Expressors (n = 35) (mean ± SD)	Non-expressors (n = 60) (mean ± SD)	P value
Tacrolimus dose (mg/kg)
At 5 days	0.08 ± 0.14	0.05 ± 0.02	0.1049
At 15 days	0.05 ± 0.03	0.05 ± 0.03	-
At 30 days	0.05 ± 0.03	0.05 ± 0.03	-
At 45 days	0.06 ± 0.03	0.05 ± 0.03	0.1205
At 90 days	0.06 ± 0.03	0.05 ± 0.03	0.1205
At 120 days	0.06 ± 0.03	0.05 ± 0.03	0.1205
At 6 months	0.06 ± 0.03	0.04 ± 0.03	0.002
At 9 months	0.06 ± 0.02	0.05 ± 0.03	0.082
At 12 months	0.06 ± 0.01	0.04 ± 0.03	0.002

Table 3 Association of cytochrome P450 3A5 polymorphism with tacrolimus trough level in expressors and non-expressors

Timeline	Expressors (n = 35) (mean ± SD)	Non-expressors (n = 60) (mean ± SD)	P value
Tacrolimus trough level (ng/mL)
At 5 days	7.6 ± 3.3	7.7 ± 3.2	0.8848
At 15 days	6.1 ± 3.0	6.8 ± 2.5	0.2249
At 30 days	6.0 ± 2.2	6.4 ± 2.0	0.3672
At 45 days	5.6 ± 2.2	6.2 ± 1.5	0.1180
At 90 days	6.7 ± 2.9	5.9 ± 2.6	0.1690
At 120 days	6.6 ± 1.9	6.1 ± 1.9	0.2191
At 6 months	6.7 ± 2.2	5.3 ± 1.2	0.001
At 9 months	6.5 ± 1.2	4.6 ± 1.2	< 0.001
At 12 months	6.2 ± 1.2	4.9 ± 0.7	< 0.001

Table 4 Renal parameters of patients with respect to polymorphism

Renal parameter	Expressors (n = 35) (mean ± SD)	Non-expressors (n = 60) (mean ± SD)	P value
Creatinine (mg/dL)
At 1 month	1.8 ± 1.6	1.5 ± 0.4	0.1694
At 3 months	1.9 ± 1.7	1.5 ± 0.4	0.0838
At 6 months	2.0 ± 1.7	1.7 ± 0.6	0.2165
At 9 months	1.9 ± 1.7	1.7 ± 0.5	0.3958
At 12 months	1.7 ± 0.5	1.7 ± 0.4	-
Estimated glomerular filtration rate levels (mL/minute/1.73 m2)
At 1 month	56.4 ± 19.4	62.6 ± 20.7	0.1531
At 3 months	56.2 ± 24.8	59.7 ± 18.2	0.4321
At 6 months	54.2 ± 28.4	54.8 ± 17.5	0.8988
At 9 months	57.9 ± 28.6	53.2 ± 17.4	0.3213
At 12 months	51.0 ± 24.0	53.4 ± 15.7	0.5573

Table 5 Complications and outcomes observed in expressor vs non-expressors

Variable	Expressors (n = 35)		Non-expressors (n = 60)		P value
	n	%	n	%
New onset diabetes after transplantation
Yes	1	2.9	3	5.0	0.6178
No	34	97.1	57	95.0
Hypomagnesemia
Yes	22	62.9	31	51.7	0.2920
No	13	37.1	29	48.3
Tuberculosis after transplant
Yes	3	8.6	8	13.3	0.8710
No	32	91.4	52	86.7
Tacrolimus discontinued permanently
Yes	8	22.9	10	16.7	0.4600
No	27	77.1	50	83.3
Biopsy-proven acute rejection
Yes	8	22.9	8	13.3	0.2340
No	27	77.1	52	86.7