Table 2.

Outcomes: patient/graft survival, renal function and structure, and acute rejection at month 12 in RTR-PD subpopulation

OutcomeBelatacept MI (n = 114)Belatacept LI (n = 97)CsA (n = 125)
Patient/graft survival
    patients surviving with functioning graft, n (%)103 (90.4)90 (92.8)101 (80.8)
        95% CI84.9 to 95.887.6 to 97.973.9 to 87.7
        weighted difference from CsA (97.3% CI)a8.5 (−0.4 to 17.4)10.2 (1.5 to 18.9)
    graft loss or death, n (%)11 (9.6)7 (7.2)24 (19.2)
    graft loss, n (%)5 (4.4)3 (3.1)16 (12.8)
    death, n (%)7 (6.1)3 (3.1)7 (5.6)
    death with functioning graft, n (%)5 (4.4)3 (3.1)6 (4.8)
    imputed as graft loss or death1 (0.9)1 (1.0)2 (1.6)
Renal function and structure
    composite renal impairment endpoint, n (%)65 (58.6)57 (64.0)102 (87.2)
    95% CI49.4 to 67.754.1 to 74.081.1 to 93.2
        weighted difference from CsA (97.3% CI)a−27.0 (−39.2 to −14.8)−21.8 (−35.1 to −8.6)
    mean iothalamate GFR (measured),b ml/min per 1.73 m2 (SE)59.8 (4.5)62.5 (4.6)45.4 (4.5)
        estimated difference from CsA (97.3% CI)c14.4 (6.0 to 22.7)17.1 (8.2 to 25.9)
    CAN, n (% [95% CI])28 (24.6 [16.7 to 22.5])32 (33.3 [23.9 to 42.8])56 (45.2 [36.4 to 3.9])
        weighted difference from CsA (97.3% CI)a−18.9 (−31.3 to −6.4)−8.2 (−22.4 to 5.9)
Acute rejection
    acute rejection, n (%)26 (22.8)20 (20.6)18 (14.4)
        95% CI15.1 to 30.512.6 to 28.78.2 to 20.6
        weighted difference from CsA (97.3% CI)a9.7 (−1.1 to 20.5)7.6 (−4.8 to 20.0)
    Banff grade, n (%)
        mild acute (1A)1 (0.9)2 (2.1)0 (0.0)
        mild acute (1B)1 (0.9)2 (2.1)1 (0.8)
        moderate acute (IIA)11 (9.6)8 (8.2)13 (10.4)
        moderate acute (IIB)12 (10.5)7 (7.2)4 (3.2)
        severe acute (III)1 (0.9)1 (1.0)0 (0.0)
  • CAN, chronic allograft nephropathy; CI, confidence interval; CsA, cyclosporine; LI, less intensive; MI, more intensive; RTR-PD, renal transplant recipients with preexisting diabetes.

  • a The DerSimonian-Laird model was used to assess risk difference with a random effect of study.

  • b Measured GFR analysis with imputation.

  • c Estimated difference evaluated using an analysis of covariance with a random effect of study.