12 June 2018 : Original article
Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study
Sehoon Park12ABCDEFG, Yon Su Kim12ABCDEG, Jungpyo Lee3ABCDEFG, Wooseong Huh4ABCDEFG, Chul Woo Yang5ABCDEFG, Young-Lim Kim6ABCDEFG, Yeong Hoon Kim7ABCDEFG, Joong Kyung Kim8ABCDEFG, Chang-Kwon Oh9ABCDEFG, Su-Kil Park10ABCDEFG*DOI: 10.12659/AOT.909036
Ann Transplant 2018; 23:401-411
Abstract
BACKGROUND: Minimizing the tacrolimus dosage in patients with stable allograft function needs further investigation.
MATERIAL AND METHODS: We performed an open-label, randomized, controlled study from 2010 to 2016 in 7 tertiary teaching hospitals in Korea and enrolled 345 kidney transplant recipients with a stable graft status. The study group received reduced-dose tacrolimus, 1080–1440 mg/day of enteric-coated mycophenolate sodium (EC-MPS), and corticosteroids. The control group received the standard tacrolimus dosage and 540–720 mg/day of EC-MPS with steroids. The primary endpoint was the mean estimated glomerular filtration rate (eGFR) and change in the eGFR at 12 months after randomization.
RESULTS: The mean tacrolimus trough level of the study group was 4.51±1.62 ng/mL, which was lower than that of the control group, at 6.75±2.82 ng/mL (P<0.001). The primary endpoint was better in the study group in terms of change in eGFR (P<0.001). The month 12 eGFRs were 73.6±28.4 and 68.3±18.1 mL/min/1.73 m² in the study and the control groups, respectively, but the difference did not reach statistical significance (P=0.07). The incidence of adverse events was similar between the study and the control groups.
CONCLUSIONS: Minimizing tacrolimus to a trough level below 5 ng/mL combined with conventional EC-MPS can be considered in patients with a steady follow-up, as it was associated with small benefits in the changes of the eGFR (Clinicaltrials.gov number: NCT01159080).
Keywords: Kidney Transplantation, Mycophenolic Acid, Tacrolimus
In Press
08 Mar 2024 : Original article
Association of Coronary Calcium Score on Cardiac PET During Pre-Kidney Transplant Assessment with Persisten...Ann Transplant In Press; DOI: 10.12659/AOT.943532
14 Mar 2024 : Original article
Impact of Blood Products Transfusion on Patients in the Immediate Post-Lung Transplant Period: A Cohort StudyAnn Transplant In Press; DOI: 10.12659/AOT.943652
14 Mar 2024 : Case report
Treatment of Cavernous Transformation of Portal Vein Caused by Hepatic Cystic Echinococcosis Using Ex Vivo ...Ann Transplant In Press; DOI: 10.12659/AOT.942358
15 Mar 2024 : Review article
Approaches and Challenges in the Current Management of Cytomegalovirus in Transplant Recipients: Highlighti...Ann Transplant In Press; DOI: 10.12659/AOT.941185
Most Viewed Current Articles
05 Apr 2022 : Original article
Impact of Statins on Hepatocellular Carcinoma Recurrence After Living-Donor Liver TransplantationDOI :10.12659/AOT.935604
Ann Transplant 2022; 27:e935604
12 Jan 2022 : Original article
Risk Factors for Developing BK Virus-Associated Nephropathy: A Single-Center Retrospective Cohort Study of ...DOI :10.12659/AOT.934738
Ann Transplant 2022; 27:e934738
22 Nov 2022 : Original article
Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipient...DOI :10.12659/AOT.937988
Ann Transplant 2022; 27:e937988
15 Mar 2022 : Case report
Combined Liver, Pancreas-Duodenum, and Kidney Transplantation for Patients with Hepatitis B Cirrhosis, Urem...DOI :10.12659/AOT.935860
Ann Transplant 2022; 27:e935860