دورية أكاديمية
Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study
| العنوان: | Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study |
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| المساهمون: | Yoshihiko Watarai, Romina Danguilan, Concesa Casasola, Shen-Shin Chang, Prajej Ruangkanchanasetr, Terence Kee, Hin Seng Wong, Takashi Kenmochi, Angel Joaquin Amante, Kuo-Hsiung Shu, Atiporn Ingsathit, Peter Bernhardt, Maria Pilar Hernandez-Gutierrez, Duck Jong Han, Myoung Soo Kim, Kim, Myoung Soo |
| بيانات النشر: | Munksgaard |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Calcineurin Inhibitors* / therapeutic use, Everolimus / therapeutic use, Glomerular Filtration Rate, Graft Rejection / drug therapy, Graft Rejection / etiology, Graft Rejection / prevention & control, Graft Survival, Humans, Immunosuppressive Agents / therapeutic use, Kidney Transplantation, Mycophenolic Acid / therapeutic use, Tacrolimus, everolimus, kidney transplant, reduced calcineurin inhibitor, reduced cyclosporine, reduced tacrolimus |
| الوصف: | Objective: We analyzed the efficacy and safety of an everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard-exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study. Methods: In this 24-month, open-label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids. Results: Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, N = 136; MPA+sCNI, N = 157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2 or treated biopsy-proven acute rejection (27.0% vs. 29.2%, P = .011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2 vs. 66.3 ml/min/1.73 m2 , P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m2 , P = .0582). Overall incidence of adverse events was comparable. BK virus (4.4% vs. 12.1%) and cytomegalovirus (4.4% vs. 13.4%) infections were significantly lower in the EVR+rCNI arm. Conclusion: This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819). ; open |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0902-0063 1399-0012 |
| العلاقة: | CLINICAL TRANSPLANTATION; J00615; OAK-2022-04801; https://ir.ymlib.yonsei.ac.kr/handle/22282913/190723Test; T9992022129; CLINICAL TRANSPLANTATION, Vol.35(10), 2021-10 |
| DOI: | 10.1111/ctr.14415 |
| الإتاحة: | https://doi.org/10.1111/ctr.14415Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/190723Test |
| حقوق: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.5BF56AE4 |
| قاعدة البيانات: | BASE |
| تدمد: | 09020063 13990012 |
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| DOI: | 10.1111/ctr.14415 |