PMID- 37897198 OWN - NLM STAT- MEDLINE DCOM- 20240207 LR - 20240418 IS - 1399-0012 (Electronic) IS - 0902-0063 (Linking) VI - 38 IP - 1 DP - 2024 Jan TI - A report of a prospective randomized trial of extended-release tacrolimus versus immediate release tacrolimus after liver transplantation with anti-thymocyte induction in a steroid free protocol. PG - e15172 LID - 10.1111/ctr.15172 [doi] AB - PURPOSE: Our study hypothesis was that once daily dosing of extended-release tacrolimus (XRT) would be a safe and effective immunosuppression (IS) with the potential to decrease adverse events (AEs) associated with immediate release tacrolimus (IRT) after liver transplantation (LT). METHODS: All patients receiving LT at our center received rabbit anti-thymocyte globulin (RATG) induction therapy. Eligible patients were randomized in a 1:1 fashion to receive either XRT or IRT. Antimicrobial prophylaxis was the same between arms, and both groups received an antimetabolite for the first 6 months following LT. Patients were then followed at pre-determined study intervals for the following year after LT. We administered the RAND-36SF survey to assess patient's health-related quality of life at pre-determined intervals. All analysis was performed with an intention to treat basis. RESULTS: We screened 194 consecutive patients and enrolled 110. Our control and study arms were well matched. Transplant characteristics were similar between groups. At all timepoints, both arms had similar serum creatinine and estimated glomerular filtration rate (eGFR), calculated by MDRD6 equation, with post-transplant GFRs between 60 and 70 mL/min/1.73 m(2) . Tacrolimus trough levels were similar between arms. The XRT arm had fewer AEs (166) and fewer serious AEs (70) compared to IRT (201 and 99, respectively). AEs most commonly were renal, infectious, or gastrointestinal in nature. While not statistically significant, XRT was held temporarily (25 vs. 35 cases) or discontinued (3 vs. 11 cases) less frequently than IRT and had fewer instances of rejection (7 vs. 12 cases). CONCLUSION: This analysis showed that XRT is safe and effective as de novo maintenance IS in a steroid-free protocol with RATG. CI - (c) 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd. FAU - Helmick, Ryan A AU - Helmick RA AUID- ORCID: 0000-0002-8819-9522 AD - Methodist Transplant Institute, Methodist University Hospital, Memphis, Tennessee, USA. AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Eymard, Corey M AU - Eymard CM AUID- ORCID: 0000-0001-8668-8333 AD - Methodist Transplant Institute, Methodist University Hospital, Memphis, Tennessee, USA. AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Naik, Surabhi AU - Naik S AUID- ORCID: 0000-0001-9496-0042 AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Eason, James D AU - Eason JD AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Nezakatgoo, Nosratollah AU - Nezakatgoo N AD - Methodist Transplant Institute, Methodist University Hospital, Memphis, Tennessee, USA. AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Nair, Satheesh AU - Nair S AUID- ORCID: 0000-0002-4167-6643 AD - Methodist Transplant Institute, Methodist University Hospital, Memphis, Tennessee, USA. AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. FAU - Vanatta, Jason M AU - Vanatta JM AUID- ORCID: 0000-0003-4777-4575 AD - Methodist Transplant Institute, Methodist University Hospital, Memphis, Tennessee, USA. AD - Department of Surgery, Division of Transplantation, University of Tennessee Health Science Center, Memphis, Tennessee, USA. LA - eng GR - IIS-2017-035/Veloxis Pharmaceuticals, Inc./ PT - Journal Article PT - Randomized Controlled Trial DEP - 20231028 PL - Denmark TA - Clin Transplant JT - Clinical transplantation JID - 8710240 RN - 0 (Immunosuppressive Agents) RN - 0 (Steroids) RN - WM0HAQ4WNM (Tacrolimus) RN - 0 (Delayed-Action Preparations) SB - IM MH - Humans MH - Graft Rejection/etiology/prevention & control MH - Immunosuppressive Agents/administration & dosage/adverse effects MH - *Liver Transplantation/adverse effects MH - Prospective Studies MH - Quality of Life MH - Steroids MH - *Tacrolimus/administration & dosage/adverse effects MH - Delayed-Action Preparations OTO - NOTNLM OT - immunosuppression OT - liver transplantation OT - quality of life OT - renal function EDAT- 2023/10/28 11:45 MHDA- 2024/01/31 06:42 CRDT- 2023/10/28 04:22 PHST- 2023/10/09 00:00 [revised] PHST- 2023/05/16 00:00 [received] PHST- 2023/10/17 00:00 [accepted] PHST- 2024/01/31 06:42 [medline] PHST- 2023/10/28 11:45 [pubmed] PHST- 2023/10/28 04:22 [entrez] AID - 10.1111/ctr.15172 [doi] PST - ppublish SO - Clin Transplant. 2024 Jan;38(1):e15172. doi: 10.1111/ctr.15172. Epub 2023 Oct 28.