Table 2.

Renal function at month 6 assessed by estimated GFR (mL/min/1.73 m²) according to Nankivell formula.

Population	Low-dose Tac group (Group A)	Standard-dose Tac group (Group B)	Treatment difference (A−B)
ITT population	n = 145	n = 137
Mean GFR	63.6	61.0	2.6
95% CI	58.8–68.4	56.2–65.9	−2.6–7.8
P value1			0.326
Observed-Cases2	n = 117	n = 111
Mean GFR	69.5	65.4	4.2
95% CI	65.1–73.9	61.0–69.7	−0.5–8.8
P value1			0.079
“As per Tac level”	n = 853	n = 693
Mean GFR	69.9	63.2	6.6
95% CI	63.1–76.6	56.0–70.4	0.4–12.9
P value1			0.038

CI: confidence interval, GFR: glomerular filtration rate.

¹For A versus B (two-sided).

²ITT population without imputation for missing data.

³“reclassified” Group: defined as >50% of Tac levels (mandatory requirement for Month 6 assessment) being within the protocol-specified Tac target range.