Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS

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 value^1			0.326
Observed-Cases^2	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 value^1			0.079
“As per Tac level”	𝑛=85^3	𝑛=69^3
Mean GFR	69.9	63.2	6.6
95% CI	63.1–76.6	56.0–70.4	0.4–12.9
P value^1			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.