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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.

作者信息

Zheng Xiang, Zhang Weijie, Zhou Hua, Cao Ronghua, Shou Zhangfei, Zhang Shuwei, Cheng Ying, Chen Xuchun, Ding Chenguang, Tang Zuofu, Li Ning, Shi Shaohua, Zhou Qiang, Chen Qiuyuan, Chen Gang, Chen Zheng, Zhou Peijun, Hu Xiaopeng, Zhang Xiaodong, Na Ning, Wang Wei

机构信息

Department of Urology, Capital Medical University Beijing Chaoyang Hospital, Beijing 100020, China.

Institute of Organ Transplantation, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430032, China.

出版信息

Chin Med J (Engl). 2022 Jul 25;135(13):1597-603. doi: 10.1097/CM9.0000000000001866.

DOI:10.1097/CM9.0000000000001866
PMID:35861301
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9532037/
Abstract

BACKGROUND: 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. METHODS: 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. CONCLUSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800017277.

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/010d/9532037/2e4e5e3ddb1b/cm9-135-1597-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/010d/9532037/2e4e5e3ddb1b/cm9-135-1597-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/010d/9532037/2e4e5e3ddb1b/cm9-135-1597-g001.jpg

相似文献

[1]
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.

Chin Med J (Engl). 2022-7-25

[2]
[Early conversion from calcineurin inhibitor to sirolimusto after renal transplantation:a prospective, open-label and non-randomized control study].

Zhonghua Yi Xue Za Zhi. 2014-11-18

[3]
Calcineurin inhibitor-free mycophenolate mofetil/sirolimus maintenance in liver transplantation: the randomized spare-the-nephron trial.

Liver Transpl. 2013-7

[4]
Conversion from calcineurin inhibitors to sirolimus of recipients with chronic kidney graft disease grade III for a period 2003-2011.

Vojnosanit Pregl. 2013-9

[5]
Decreased acute rejection and improved renal allograft survival using sirolimus and low-dose calcineurin inhibitors without induction therapy.

Int J Artif Organs. 2009-6

[6]
High incidence of rejection episodes and poor tolerance of sirolimus in a protocol with early steroid withdrawal and calcineurin inhibitor-free maintenance therapy in renal transplantation: experiences of a randomized prospective single-center study.

Transplant Proc. 2012-12

[7]
Conversion from calcineurin inhibitor to either mycophenolate mofetil or sirolimus improves renal function in liver transplant recipients with chronic kidney disease: results of a prospective randomized trial.

Transplant Proc. 2010-12

[8]
Renal function, efficacy, and safety of sirolimus and mycophenolate mofetil after short-term calcineurin inhibitor-based quadruple therapy in de novo renal transplant patients: one-year analysis of a randomized multicenter trial.

Transplantation. 2010-7-27

[9]
Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial.

Transplantation. 2009-1-27

[10]
Calcineurin inhibitor-sparing regimens in solid organ transplantation: focus on improving renal function and nephrotoxicity.

Clin Transplant. 2008

引用本文的文献

[1]
Identification of M2 macrophage-related biomarkers for a predictive model of interstitial fibrosis and tubular atrophy after kidney transplantation by machine learning algorithms.

Transl Androl Urol. 2025-7-30

[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]
Interventions for BK virus infection in kidney transplant recipients.

Cochrane Database Syst Rev. 2024-10-9

[4]
Construction of predictive model of interstitial fibrosis and tubular atrophy after kidney transplantation with machine learning algorithms.

Front Genet. 2023-11-1

本文引用的文献

[1]
Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients.

Transplant Direct. 2016-3-3

[2]
A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients.

Clin Transplant. 2016-5

[3]
Planned randomized conversion from tacrolimus to sirolimus-based immunosuppressive regimen in de novo kidney transplant recipients.

Am J Transplant. 2013-10-30

[4]
Annual Data Report of the US Organ Procurement and Transplantation Network (OPTN) and the Scientific Registry of Transplant Recipients (SRTR). Preface.

Am J Transplant. 2013-1

[5]
Early conversion to a sirolimus-based, calcineurin-inhibitor-free immunosuppression in the SMART trial: observational results at 24 and 36months after transplantation.

Transpl Int. 2012-2-10

[6]
'United States Renal Data System 2011 Annual Data Report: Atlas of chronic kidney disease & end-stage renal disease in the United States.

Am J Kidney Dis. 2012-1

[7]
Do wound complications or lymphoceles occur more often in solid organ transplant recipients on mTOR inhibitors? A systematic review of randomized controlled trials.

Transpl Int. 2011-9-29

[8]
Conversion of long-term kidney transplant recipients from calcineurin inhibitor therapy to everolimus: a randomized, multicenter, 24-month study.

Transplantation. 2011-8-27

[9]
The ORION study: comparison of two sirolimus-based regimens versus tacrolimus and mycophenolate mofetil in renal allograft recipients.

Am J Transplant. 2011-6-10

[10]
Sirolimus for calcineurin inhibitors in organ transplantation: contra.

Kidney Int. 2010-8-11

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