Korean J Transplant.
2023 Nov;37(Suppl 1):S222. 10.4285/ATW2023.F-8120.
Efficacy and safety of generic once-daily prolonged release tacrolimus (TacroBell SR cap.) in de novo kidney transplant recipients: a multicenter, non-comparative, phase IV study
- Affiliations
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- 1Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
- 2Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
- 3Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, Korea
- 4Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea
- 5Department of Internal Medicine, Bong Seng Memorial Hospital, Busan, Korea
- 6Department of Internal Medicine, Maryknoll Medical Center, Busan, Korea
- 7Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- 8Department of Surgery, Ajou University School of Medicine, Suwon, Korea
- 9Department of Surgery, Jeonbuk National University College of Medicine, Jeonju, Korea
- KMID: 2551842
- DOI: http://doi.org/10.4285/ATW2023.F-8120
Abstract
- Background
Once-daily tacrolimus administration has demonstrated improved medication compliance in compared to twice-daily dosing. However, the safety and efficacy of generic once-daily tacrolimus in de novo kidney transplant recipients remain underexplored.
Methods
We investigated the efficacy and safety of generic once-daily tacrolimus during the 6 months following de novo kidney transplantation. This prospective, multicenter, open-label, single-arm study was conducted across 10 transplant centers (NCT03749356). The primary endpoint was the composite efficacy failure rate, including biopsy-proven acute T-cell mediated rejection, graft loss, death or loss to follow-up, within 24 weeks posttransplantation. Among the 147 screened kidney transplant candidates, 141 were enrolled, and 121 successfully completed the study.
Results
The primary efficacy failure rates were 5.0% in the full-analysis set and 5.8% in the per-protocol set. During the follow-up, there were no cases of graft loss, but one patient died with a functioning graft due to acute respiratory distress syndrome. Eight patients experienced biopsy-proven acute rejection (six T-cell mediated rejections and two antibody-mediated rejections). The mean estimated glomerular filtration rate at 24 weeks was 64.7 mL/min/1.73 m2. In the full-analysis set, adverse events and serious adverse events with a suspected relation to study drug occurred in 56.0% and 8.5% of cases, respectively. Of the 17 participants who dropped out from the study, 7 discontinued study drug due to difficulties in regulating whole-blood tacrolimus trough concentrations within the target range.
Conclusions
This study suggests that generic once-daily tacrolimus is both effective and safe for use in de novo kidney transplant patients.
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