Table 2.

Clinical trials of belatacept in renal transplantation

Trial	Treatment groups	Acute rejection	Graft loss	GFR at end of study (mL/min)	Notes
Phase II, 6-month, randomized, partially blinded, parallel group38	MI belatacept	5/74 (7%)	3/74 (4%)	66*	Basiliximab induction with MMF + steroids as maintenance
	LI belatacept	4/71 (6%)	1/71 (1%)	62**
	CsA	6/73 (8%)	2/73 (3%)	54
Phase II, 1-year, randomized, openlabel39	Belatacept + MMF	5/33 (15%)	2/33 (6%)	64	Thymoglobulin induction.
	Belatacept + sirolimus	1/26 (4%)	2/26 (8%)	62	P values not reported
	tacrolimus + MMF	1/30 (3%)	0/30 (0%)	54
Phase II, randomized, partially blinded, multicenter (BENEFIT)40	MI belatacept	49/219 (22%)	4/219 (2%)	65§	One year results. Basiliximab induction with MMF + steroids as maintenance
	LI belatacept	39/226 (17%)	5/226 (2%)	63§
	CsA	16/221 (7%)	8/221 (4%)	50
Phase III, randomized, partially blinded, multicenter (BENEFIT-EXT)42	MI belatacept	33/184 (18%)	17/184 (9%)	52†	One-year results. Basiliximab induction with MMF + steroids as maintenance
	LI belatacept	31/175 (18%)	16/175 (9%)	49††
	CsA	26/184 (14%)	20/184 (11%)	45

Abbreviations: GFR, estimated glomerular filtration rate; MI, more intensive; MMF, mycophenolate mofetil; CsA, cyclosporine A; LI, less intensive; BENEFIT, Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial; BENEFIT-EXT, Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-EXTended criteria donors.

^*Notes: P = 0.01;

^**P = 0.04 versus standard CsA;

^§P < 0.01 versus standard CsA;

^†P < 0.01;

^††P = 0.1 versus standard CsA.