Three-Year Outcomes in Kidney Transplant Patients Randomized to Steroid-Free Immunosuppression or Steroid Withdrawal, with Enteric-Coated Mycophenolate Sodium and Cyclosporine: The Infinity Study

Table 3

Efficacy endpoints at month 36, 𝑛 (%).

	Steroid avoidance (𝑛=70)	Steroid withdrawal (𝑛=61)	𝑃 value
Treatment failure^a	15 (21.4)	10 (16.4)	0.46^b
BPAR^c	14 (20.0)	7 (11.5)	0.19^b
Grade IA	9	3
Grade IB	2	1
Grade IIA	1	3
Graft loss	1 (1.4)	0 (0.0)	1.00^d
Death	2 (2.9)	2 (3.3)	1.00^d
Loss to follow-up	0 (0.0)	2 (3.3)	0.22^d

BPAR: biopsy-proven acute rejection.
^aTreatment failure was defined as BPAR (central review), graft loss, death or loss to follow-up. BPAR detected on the 3-month protocol biopsy was excluded.
^bChi-squared test.
^cIf a patient experienced more than one episode of BPAR, only the highest rejection grade is shown.
^dFisher’s exact test.