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依维莫司辅助下降低亚洲肾移植受者中环孢素用量：转化研究亚组分析的 2 年结果。

Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study.

机构信息

Department of Transplant Surgery, Kidney Disease Center, Nagoya Daini Red Cross Hospital, Nagoya, Japan.

Department of Adult Nephrology, National Kidney and Transplant Institute, Quezon City, Philippines.

出版信息

Clin Transplant. 2021 Oct;35(10):e14415. doi: 10.1111/ctr.14415. Epub 2021 Sep 23.

DOI:10.1111/ctr.14415
PMID:34216395
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9255374/
Abstract

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 m 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 m , P = .0414) even after adjusting for donor type and donor age (64.3 vs. 59.3 ml/min/1.73 m , 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).

摘要

目的：我们分析了依维莫司联合低剂量钙调磷酸酶抑制剂（EVR+rCNI）与吗替麦考酚酯联合标准剂量钙调磷酸酶抑制剂（MPA+sCNI）方案在 TRANSFORM 研究中亚洲患者中的疗效和安全性。

方法：在这项为期 24 个月、开放标签的研究中，初治肾移植受者（KTxR）按 1:1 比例随机分配至 EVR+rCNI 或 MPA+sCNI 组，同时接受诱导治疗和皮质类固醇治疗。

结果：在 TRANSFORM 研究的 2037 例随机患者中，有 293 例为亚洲人（EVR+rCNI，N=136；MPA+sCNI，N=157）。在 24 个月时，EVR+rCNI 在估计肾小球滤过率（eGFR）<50ml/min/1.73m 或治疗后证实的急性排斥反应的二项终点方面不劣于 MPA+sCNI（27.0%比 29.2%，非劣效性边界为 10%，P=0.011）。两组各有 1 例患者报告发生移植物丢失和死亡。EVR+rCNI 组的平均 eGFR 高于 MPA+sCNI 组（72.2ml/min/1.73m 比 66.3ml/min/1.73m，P=0.0414），即使在校正供体类型和供体年龄后（64.3ml/min/1.73m 比 59.3ml/min/1.73m，P=0.0582）。总体不良事件发生率相当。EVR+rCNI 组的 BK 病毒（4.4%比 12.1%）和巨细胞病毒（4.4%比 13.4%）感染明显更低。

结论：在亚洲初治肾移植受者的亚组分析中，EVR+rCNI 与 MPA+sCNI 方案在提供相当的抗排斥反应疗效、更好的肾功能和降低病毒感染方面具有优势（NCT01950819）。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/041eaf4353db/CTR-35-0-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/11e3b2518138/CTR-35-0-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/b6619b87ee69/CTR-35-0-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/22750bafb189/CTR-35-0-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/041eaf4353db/CTR-35-0-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/11e3b2518138/CTR-35-0-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/b6619b87ee69/CTR-35-0-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/22750bafb189/CTR-35-0-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f84c/9255374/041eaf4353db/CTR-35-0-g002.jpg

相似文献

[1]
Everolimus-facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2-year results from the subgroup analysis of the TRANSFORM study.

Clin Transplant. 2021-10

[2]
Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study.

Am J Transplant. 2019-7-1

[3]
Cardiovascular Outcomes in De Novo Kidney Transplant Recipients Receiving Everolimus and Reduced Calcineurin Inhibitor or Standard Triple Therapy: 24-month Post Hoc Analysis From TRANSFORM Study.

Transplantation. 2023-7-1

[4]
Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: insights from the 24-month TRANSFORM study.

Expert Opin Drug Saf. 2020-10

[5]
An open-label, randomized trial indicates that everolimus with tacrolimus or cyclosporine is comparable to standard immunosuppression in de novo kidney transplant patients.

Kidney Int. 2019-2-27

[6]
Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.

J Am Soc Nephrol. 2018-5-11

[7]
Efficacy and Safety of Everolimus Plus Low-Dose Tacrolimus Versus Mycophenolate Mofetil Plus Standard-Dose Tacrolimus in De Novo Renal Transplant Recipients: 12-Month Data.

Am J Transplant. 2017-5

[8]
Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study.

BMJ Open. 2021-10-7

[9]
Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation.

Transplantation. 2013-4-15

[10]
Safety of Everolimus With Reduced Calcineurin Inhibitor Exposure in De Novo Kidney Transplants: An Analysis From the Randomized TRANSFORM Study.

Transplantation. 2019-9

引用本文的文献

[1]
Utility of the ELISpot Test to Predict the Risk of Developing BK Polyomavirus Nephropathy in Kidney Recipients, a Multicenter Study.

Vaccines (Basel). 2025-7-28

[2]
Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function.

Cochrane Database Syst Rev. 2025-4-8

[3]
The estimation of healthcare cost of kidney transplantation in Japan using large-scale administrative databases.

Clin Exp Nephrol. 2025-3

[4]
Lung cancer after kidney transplantation: a 50-year experience at a single institution.

Surg Today. 2024-10

本文引用的文献

[1]
Two-year outcomes in de novo renal transplant recipients receiving everolimus-facilitated calcineurin inhibitor reduction regimen from the TRANSFORM study.

Am J Transplant. 2019-7-1

[2]
Everolimus-based Immunosuppression Possibly Suppresses Mean Fluorescence Intensity Values of De Novo Donor-specific Antibodies After Primary Kidney Transplantation.

Transplant Proc. 2019-6

[3]
OPTN/SRTR 2017 Annual Data Report: Kidney.

Am J Transplant. 2019-2

[4]
Asian Americans & chronic kidney disease in a nationally representative cohort.

BMC Nephrol. 2019-1-9

[5]
Trends in the Causes of Death among Kidney Transplant Recipients in the United States (1996-2014).

Am J Nephrol. 2018-11-23

[6]
Risk factors associated with post-kidney transplant malignancies: an article from the Cancer-Kidney International Network.

Clin Kidney J. 2018-6

[7]
Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation.

J Am Soc Nephrol. 2018-5-11

[8]
Early Conversion From Calcineurin Inhibitor- to Everolimus-Based Therapy Following Kidney Transplantation: Results of the Randomized ELEVATE Trial.

Am J Transplant. 2017-2-14

[9]
Efficacy and Safety of Everolimus Plus Low-Dose Tacrolimus Versus Mycophenolate Mofetil Plus Standard-Dose Tacrolimus in De Novo Renal Transplant Recipients: 12-Month Data.

Am J Transplant. 2017-5

[10]
5-year follow-up of a randomized clinical study comparing everolimus plus reduced-dose cyclosporine with mycophenolate mofetil plus standard-dose cyclosporine in de novo kidney transplantation: Retrospective single center assessment.

Int Immunopharmacol. 2016-10

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