Current state of renal transplant immunosuppression: Present and future

Table 5 Summary of the Belatacept trials

Study	Phase II			Benefit			Benefit-EXT
Author	Vincenti			Vincenti			Durrbach
Induction	Basiliximab			Basiliximab			Basiliximab
Study drug	MI bela	LI bela	CsA	MI bela	LI bela	CsA	MI bela	LI bela	CsA
Maintenance	MMF + steroids			MMF + steroids			MMF + steroids
Demographics
No. of patients	74	71	73	225	230	231	193	193	192
Age (yr)	47	42	46	44	43	44	57	56	56
Deceased donor (%)	69	73	78	42			100	100	100
Female (%)	27	32	33	31	35	25	35	26	37
Re-transplantation (%)	1	6	3	4	3	6	Not reported
PRA > 20% (%)	1	3	1	11	13	8	0	1	3
African-American (%)	8	9	8	7	10	8	14	14	12
CIT (h)	20	20	18	16.3			Not reported
CIT (> 24 h) (%)	Not reported			Not reported			39	43	44
Delayed graft function (%)	Not reported			16	14	18	47	47	49
Endpoints 6-12 mo	6 mo			12 mo			12 mo
Acute rejection (%)	7	6	8	22	17	7	18	18	14
Acute Rejection (Grade II) (%)	4	5	6	17	11	4	14	15	12
Measured GFR (mL/min)	66	62	54	65	63	50	52	50	45
NODAT (%)	Not reported			7	4	10	2	5	9
CAN (Stage II or III) (%)	8	9	9	4	6	7	10	12	4
Endpoints 12 mo
Graft survival (%)	99	100	95	98	98	96	91	91	89
Patient survival (%)	96	99	97	97	98	97	96	98	96
Cancer	2	0	2	4	3	1	4	4	6
PTLD	2	0	0	1	1	0	3	3	0
Endpoints 2 yr
Acute rejection				24	17	9	17	18	15
Measured GFR (mL/min)				65	68	51	52	50	45
Graft survival (%)				94	95	91	83	84	93
Patient survival (%)				97	97	94	93	94	94
Endpoints 3 yr
Acute rejection (%)				24	17	10	18	19	16
Measured GFR (mL/min)				65	66	44	43	42	32
Patient/graft survival (%)				92	92	89	80	82	80

CsA: Cyclosporine; MI: More intensive; LI: Less intensive; PTLD: Post-transplant lymphoproliferative disorder; NODAT: New onset of diabetes mellitus after transplantation; CIT: Cold ischemia time; GFR: Glomerular filtration rate.