Renal Function Outcomes With Tacrolimus QD After De Novo Liver Transplantation for Different Baseline eGFR: Ad Hoc Analysis From the DIAMOND Randomized Controlled Trial.

Investigate the effect of baseline eGFR on renal function at Wk 24 with tacrolimus QD. Arm 1: tacrolimus QD (initial dose: 0.2mg/kg/day); Arm 2: tacrolimus QD (initial dose: 0.15-0.175mg/kg/day)+basiliximab; Arm 3: tacrolimus QD (initial dose: 0.2mg/kg/day delayed to Day 5)+basiliximab. All received MMF+1x bolus steroid only. Primary analysis: eGFR (MDRD4); sub-analysis: eGFR by baseline eGFR ≥60, 30-59 and <30mL/min/1.73m2. Both used full analysis set (283, 287, 274), Wk 24. Comparable baseline characteristics. Tacrolimus trough levels were initially lower in Arm 2 vs 1, tacrolimus delayed until Day 5 in Arm 3; trough levels in all arms comparable by Day 28. eGFR Arms 2/3 vs 1: 76.4/73.3 vs 67.4mL/min/1.73m2 (p=0.001; 0.047). Baseline eGFR ≥60mL/min/1.73m2: change to Wk 24 was less in Arm 2 vs 1 (p=0.0231). Baseline eGFR 30-59mL/min/1.73m2: improvements in renal function to Wk 24 for Arms 2/3. Baseline eGFR <30mL/min/1.73m2: improvements in renal function in all arms (table).Table: No Caption available.In pts with baseline eGFR ≥60mL/min/1.73m2, initial lower dose tacrolimus QD (0.15-0.175mg/kg/day) in Arm 2 resulted in better renal function at 24 wks vs higher initial dose tacrolimus QD (0.2mg/kg/day) in Arm 1. In pts with baseline eGFR 30-59mL/min/1.73m2, both Arms 2 and 3 (delayed tacrolimus QD introduction) had better renal function vs Arm 1. Similarly, in pts with baseline eGFR <30mL/min/1.73m2, both Arms 2/3 had better renal function vs Arm 1 with the greatest improvement seen in Arm 3, although pt numbers were low in this group. DISCLOSURES:Klempnauer, J.: Other, Astellas, Support, Novartis, Support, Roche, Support, BMS, Support, Genzyme, Support. Bechstein, W.: Other, Astellas, Honoraria and advisory boards. Friman, S.: Other, Astellas, Honoraria, Roche, Honoraria, BMS, Honoraria. Isoniemi, H.: Other, Astellas, Consulting fee and advisory boards, Roche, Advisory boards. Brown, M.: Employee, Astellas. Undre, N.: Employee, Astellas. Trunecka, P.: Other, Astellas, Advisory boards and consultancy agreements, Pfizer, Speaker honoraria.