Table 2.

Clinical trial results

Bodyweight (kg)	CYP3A5	Donor	Day 3		Day 7		Day 10
			Tac dose (mg/kg/day)	Tac C0	Tac dose (mg/kg/day)	Tac C0	Tac dose (mg/kg/day)	Tac C0
65	*3/*3	LD	0.31	11.3	0.31	17.8	0.25	14.9
80.4	*1/*3	DD	0.80	21.4a	0.22	35.0	0.22	15.7
48.2	*1/*1	DD	0.79	17.9a	0.29	15.3	0.37	4.6
51.3	*3/*3	DD	0.39	9.8	0.39	16.9	0.31	13.3
15.7	*3/*3	LD	0.38	7.4	0.51	12.0	0.51	9.7
70.1	*3/*3	LD	0.29	4.2	0.43	16.0	0.37	20.8
62.2	*1/*3	DD	0.64	11b	0.48	18.6	0.42	17.7
57.7	*3/*3	LD	0.29	11.9	0.33	22.2	0.26	13.7
29.9	*1/*3	LD	0.54	4.1	0.67	8.5	0.67	10.6
26.3	*3/*3	DD	0.46	7.2	0.61	14.6	0.53	14.4
39.3	*3/*3	LD	0.31	5.3	0.31	23.5	0.15	18.1
49.3	*3/*3	LD	0.28	24	0.20	17.4	0.12	16.7
41.5	*3/*3	LD	0.31	10.9	NAc	NA	NA	NA
63.6	*3/*3	LD	0.31	10.3	0.31	11.7	0.19	8.0
59.3	*3/*3	LD	0.30	10.8	0.24	21.3	0.17	22.3
19.3	*3/*3	LD	0.36	21.3	0.26	21.3	0.21	NA

C₀ pre-dose concentration, CYP cytochrome P450, DD deceased donor, LD living donor, NA not available, Tac tacrolimus

^aPatients had a toxic tacrolimus C₀ on days 1–2 following transplantation. The tacrolimus dose was subsequently reduced

^bPatient had a concentration of 11 ng/mL after just one dose of tacrolimus. The tacrolimus dose was subsequently reduced

^cPatient discontinued the study after accidental administration of Advagraf