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A Randomized Controlled Clinical Trial of Thymoglobulin® and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection after Liver Transplantation: A Multicenter Study

L. Coromina1, S. Shah2, B. Xervos3, M. Zimmerman4, K. Sasaki1, T. Diago1, K. Hashimoto1, F. Aucejo1, m. Fujiki1, H. Block-Beach1, A. Patterson2, C. Miller1, C. Quintini1, B. Eghtesad1

1The Cleveland Clinic, Cleveland, OH, 2University of Cincinnati, Cincinnati, OH, 3The Cleveland Clinic, Weston, FL, 4Medical College of Wisconsin, Milwaukee, WI

Meeting: 2019 American Transplant Congress

Abstract number: 550

Keywords: Immunosuppression, Induction therapy, Liver transplantation, Renal function

Session Information

Session Name: Concurrent Session: Liver - Kidney Issues in Liver Transplantation

Session Type: Concurrent Session

Date: Tuesday, June 4, 2019

Session Time: 4:30pm-6:00pm

 Presentation Time: 4:30pm-4:42pm

Location: Room 302

*Purpose: Thymoglobulin® (r-ATG) has been used as induction therapy in liver transplantation (LT). No prospective, randomized, controlled, trial (RCT) has been performed to evaluate effect of r-ATG induction and delayed initiation of CNI on long-term renal function after LT

*Methods: 110 patients were randomized to r-ATG induction with delayed initiation of CNI for 10 days after LT, and standard CNI group, at 4 transplant programs. The eGFR and delta GFR were measured at 1, 3, 6, 9, and 12-month milestones for analysis

*Results: The median age, MELD score, baseline creatinine, baseline eGFR, and gender were similar between the two groups (all P>0.05). The median baseline, post-1, -3, -6, -9 and -12 month eGFR in CNI vs r-ATG groups were 88.0 vs. 91.6 (0.18), 82.0 vs. 93.5 (P=0.045), 75.0 vs. 86.0 (P=0.046), 74.0 vs. 79.0 (P=0.15), 69.5 vs. 97.0 (P=0.01), and 73.0 vs.90.0 (P=0.08). The median delta eGFR at 12 months after transplant was better in r-ATG group although it did not reach statistically significant (-21 vs -12, P=0.23). The time-weighted average of CNI levels were similar between two groups (CNI group; 7.2ng/mL r-ATG group 7.5ng/mL P=0.60). The chronological changes of median and interquartile ranges of eGFR and delta eGFR according to pre-transplant GFR (≥ or <80) were shown in Figure 1, and Table 1. The protective influence of r-ATG was more pronounced (approaching significance), in patients with lower initial GFR at LT

*Conclusions: Early initiation of CNI has shown to affect long-term renal function after LT. Induction with r-ATG and delayed initiation of CNI seems to be protective of long-term renal function in LT. This effect is seen at every milestone of follow up but more pronounced in patients with initial degree of renal dysfunction, especially in the era of LT in high-MELD recipients

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eGFR longitudinal Changes
Baseline 88 (75-111) 91 (80-132) 0.18
1 month 82 (54-102) 93 (68-124) 0.045
3 months 75 (57-110) 86 (76-117) 0.046
6 months 74 (58-98) 79 (64-107) 0.15
9 months 69 (62-88) 97 (77-129) 0.01
12 months 73 (60-87) 90 (61-122) 0.08
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To cite this abstract in AMA style:

Coromina L, Shah S, Xervos B, Zimmerman M, Sasaki K, Diago T, Hashimoto K, Aucejo F, Fujiki m, Block-Beach H, Patterson A, Miller C, Quintini C, Eghtesad B. A Randomized Controlled Clinical Trial of Thymoglobulin® and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection after Liver Transplantation: A Multicenter Study [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/a-randomized-controlled-clinical-trial-of-thymoglobulin-and-extended-delay-of-calcineurin-inhibitor-therapy-for-renal-protection-after-liver-transplantation-a-multicenter-study/. Accessed May 9, 2025.

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