Randomized, Phase 4 Study Evaluating the Pharmacokinetics and Tolerability of the New Tacrolimus Tablet Formulation (Tacrobell Tab) in Kidney Transplant Recipients
1Department of Surgery, Seoul National University College of Medicine, Seoul, Korea, Republic of, 2Seoul National University Hospital, Seoul, Korea, Republic of, 3Department of Nephrology, Seoul National University College of Medicine, Seoul, Korea, Republic of, 4Department of Clnical Pharmacology, Seoul National University Hospital, Seoul, Korea, Republic of
Meeting: 2022 American Transplant Congress
Abstract number: 1709
Keywords: Immunosuppression, Kidney transplantation
Topic: Clinical Science » Kidney » 38 - Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Information
Session Name: Kidney Immunosuppression: Novel Regimens and Drug Minimization
Session Type: Poster Abstract
Date: Tuesday, June 7, 2022
Session Time: 7:00pm-8:00pm
Presentation Time: 7:00pm-8:00pm
Location: Hynes Halls C & D
*Purpose: Previous twice-a-day tacrolimus formulations available were capsular and of limited dose formulations (0.5mg, 1mg). Recently a new tablet formulation of tacrolimus with more diverse dose formulations was released by Chong Kun Dang Pharmaceutical Corp. We conducted a randomized controlled study between the new Tacrobell tablet formulation and innovator drug Prograf (Astellas) to compare the pharmacokinetics and tolerability profiles in renal transplant recipients.
*Methods: PK-TACT was a parallel randomized, single-center, open-label, Phase IV study to evaluate pharmacokinetic profile and clinical efficacy of the Tacrobell tablet formation compared to Prograf in de novo renal transplant recipients. Study drugs were administered as the primary immunosuppressant for six months, starting from the perioperative period. Study participants were stratified by donor type (living vs. deceased) and by expression of CYP3A5. Pharmacokinetic analysis was performed in all patients at 2 and 24 weeks post-transplant. We assessed the bioequivalence of the two study drug based on Cmax, AUCt, Tmax, and AUC∞ at 2 and 24 weeks. Tolerability was assessed through graft outcome (renal function, survival, biopsy-proven acute rejection) as well as adverse events
*Results: A total of 131 patients were enrolled. In the full analysis set of 117 patients (Tacrobell tab., n=57; Prograf, n=60) who completed the 2-week post-transplant PK analysis, mean Cmax was 31.281 ± 13.37 μg/L and 28.119 ± 9.619 μg/L respectively, and the mean AUCt was 218.028 ± 57.127 μg·h/L and 202.713 ± 48.909 μg·h/L. The geometric mean ratio of Cmax and AUCt at 2 weeks was 1.08 (90% CI 0.96-1.22) and 1.07 (90% CI, 0.98-1.16), meeting the conventional bioequivalence criteria. The dose-normalized Cmax and AUCt were also comparable in both post-transplant 2 and 24 weeks PK analysis. Graft function at post 2, 4, 14, and 24 weeks post-transplant was similar between the two groups. There were 10 (17.5%) and 8 (13.3%) subjects with biopsy-proven rejection in the Tacrobell tab. and the Prograf group (p=0.71). During the study period, there was one graft loss in the Tacrobell group and one patient death in the Prograf group due to fulminant hepatitis of unknown origin.
*Conclusions: The new Tacrobell tablet formulation was shown to be bioequivalent and of comparable clinical efficacy compared to the innovator drug Prograf following current FDA bioequivalence metrics.
To cite this abstract in AMA style:
Han A, Cho E, Woo HY, Ara C, Lee H, Kim Y, Park Y, Oh J, Min S, Ha J. Randomized, Phase 4 Study Evaluating the Pharmacokinetics and Tolerability of the New Tacrolimus Tablet Formulation (Tacrobell Tab) in Kidney Transplant Recipients [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/randomized-phase-4-study-evaluating-the-pharmacokinetics-and-tolerability-of-the-new-tacrolimus-tablet-formulation-tacrobell-tab-in-kidney-transplant-recipients/. Accessed May 16, 2025.« Back to 2022 American Transplant Congress