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A randomized controlled trial to evaluate efficacy and safety of early conversion to a low-dose calcineurin inhibitor combined with sirolimus in renal transplant patients

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收录情况： ◇ SCIE ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越：领军期刊 ◇ 中华系列

作者：
Zheng Xiang[1] * ; Zhang Weijie[2] ; Zhou Hua[3] ; Cao Ronghua[4] ; Shou Zhangfei[5] ; Zhang Shuwei[6] ; Cheng Ying[7] ; Chen Xuchun[7] ; Ding Chenguang[8] ; Tang Zuofu[9] ; Li Ning[3] ; Shi Shaohua[3] ; Zhou Qiang[10] ; Chen Qiuyuan[4] ; Chen Gang[2] ; Chen Zheng[11] ; Zhou Peijun[12] ; Hu Xiaopeng[1] ; Zhang Xiaodong[1] ; Na Ning[9] ; Wang Wei[1,*1] ;
机构： [1]Department of Urology, Capital Medical University Beijing Chaoyang Hospital, Beijing 100020, China. [2]Institute of Organ Transplantation, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430032, China. [3]Kidney Transplantation Dialysis Center, The Second People's Hospital of Shanxi Province, Taiyuan, Shanxi 030012, China. [4]Department of Organ Transplantation, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong 510120, China. [5]Department of Nephrology, Shulan (Hangzhou) Hospital, Hangzhou, Zhejiang 310000, China. [6]Department of Urology, Ningbo Yinzhou Number. 2 Hospital, Ningbo, Zhejiang 315000, China. [7]Department of Organ Transplantation, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning 110001, China. [8]Institute of Kidney Transplantation, The First Affiliated Hospital, Medical College of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, China. [9]Department of Kidney, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China. [10]Department of Kidney, Southwest Hospital, The First Hospital Affiliated to The Third Military Medical University (Army Medical University), Chongqing 400000, China. [11]Organ Transplant Center, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510260, China. [12]Kidney Transplantation Center, Department of Urology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200000, China.
出处：
DOI： 10.1097/CM9.0000000000001866
ISSN：

关键词： Calcineurin inhibitor Conversion Rapamycin Renal transplantation Sirolimus

摘要：
The calcineurin inhibitor (CNI)-based immune maintenance regimen that is commonly used after renal transplantation has greatly improved early graft survival after transplantation; however, the long-term prognosis of grafts has not been significantly improved. The nephrotoxicity of CNI drugs is one of the main risk factors for the poor long-term prognosis of grafts. Sirolimus (SRL) has been employed as an immunosuppressant in clinical practice for over 20 years and has been found to have no nephrotoxic effects on grafts. Presently, the regimen and timing of SRL application after renal transplantation vary, and clinical data are scarce. Multicenter prospective randomized controlled studies are particularly rare. This study aims to investigate the effects of early conversion to a low-dose CNI combined with SRL on the long-term prognosis of renal transplantation.Patients who receive four weeks of a standard regimen with CNI + mycophenolic acid (MPA) + glucocorticoid after renal transplantation in multiple transplant centers across China will be included in this study. At week 5, after the operation, patients in the experimental group will receive an additional administration of SRL, a reduction in the CNI drug doses, withdrawal of MPA medication, and maintenance of glucocorticoids. In addition, patients in the control group will receive the maintained standard of care. The patients' vital signs, routine blood tests, routine urine tests, blood biochemistry, serum creatinine, BK virus (BKV)/ cytomegalovirus (CMV), and trough concentrations of CNI drugs and SRL at the baseline and weeks 12, 24, 36, 48, 72, and 104 after conversion will be recorded. Patient survival, graft survival, and estimated glomerular filtration rate will be calculated, and concomitant medications and adverse events will also be recorded.The study data will be utilized to evaluate the efficacy and safety of early conversion to low-dose CNIs combined with SRL in renal transplant patients.Chinese Clinical Trial Registry, ChiCTR1800017277.Copyright © 2022 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.

基金：
China International Medical Foundation (No. RUPUS-ISRT-20180114).
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类 | 3 区 医学
小类 | 3 区 医学：内科
最新[2025]版：
大类 | 2 区 医学
小类 | 2 区 医学：内科
JCR分区：
出版当年[2020]版：
Q2 MEDICINE, GENERAL & INTERNAL
最新[2023]版：
Q1 MEDICINE, GENERAL & INTERNAL

影响因子： 最新[2023版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者：
第一作者机构： [1]Department of Urology, Capital Medical University Beijing Chaoyang Hospital, Beijing 100020, China.
通讯作者：
通讯机构： [1]Department of Urology, Capital Medical University Beijing Chaoyang Hospital, Beijing 100020, China. [*1]Department of Urology, Beijing Chaoyang Hospital, Capital Medical University, Workers Stadium, South Road No. 8, Building B, 7th Floor, Beijing 100020, China
推荐引用方式(GB/T 7714)：
Zheng Xiang,Zhang Weijie,Zhou Hua,et al.A randomized controlled trial to evaluate efficacy and safety of early conversion to a low-dose calcineurin inhibitor combined with sirolimus in renal transplant patients[J].CHINESE MEDICAL JOURNAL.2022,135(13):1597-1603.doi:10.1097/CM9.0000000000001866.
APA：
Zheng Xiang,Zhang Weijie,Zhou Hua,Cao Ronghua,Shou Zhangfei...&Wang Wei.(2022).A randomized controlled trial to evaluate efficacy and safety of early conversion to a low-dose calcineurin inhibitor combined with sirolimus in renal transplant patients.CHINESE MEDICAL JOURNAL,135,(13)
MLA：
Zheng Xiang,et al."A randomized controlled trial to evaluate efficacy and safety of early conversion to a low-dose calcineurin inhibitor combined with sirolimus in renal transplant patients".CHINESE MEDICAL JOURNAL 135..13(2022):1597-1603

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