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. 2022 Jul 25;135(13):1597-1603.
doi: 10.1097/CM9.0000000000001866. Online ahead of print.

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

Xiang Zheng  1 , Weijie Zhang  2 , Hua Zhou  3 , Ronghua Cao  4 , Zhangfei Shou  5 , Shuwei Zhang  6 , Ying Cheng  7 , Xuchun Chen  7 , Chenguang Ding  8 , Zuofu Tang  9 , Ning Li  3 , Shaohua Shi  3 , Qiang Zhou  10 , Qiuyuan Chen  4 , Gang Chen  2 , Zheng Chen  11 , Peijun Zhou  12 , Xiaopeng Hu  1 , Xiaodong Zhang  1 , Ning Na  9 , Wei Wang  1
Affiliations

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

Xiang Zheng et al. Chin Med J (Engl). .

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.

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Conflict of interest statement

We declare that we have no financial and personal relationships with other people or organizations that can inappropriately influence our work, there is no professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in, or the review of, the manuscript entitled.

Figures

Figure 1
Figure 1
Study flow diagram. CNI: Calcineurin inhibitor; MPA: Mycophenolic acid; SRL: Sirolimus; TAC: Tacrolimus; MMF: Mycophenolate mofetil.
See this image and copyright information in PMC

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