Oncotarget

Clinical Research Papers:

Efficacy and safety of a reduced calcineurin inhibitor dose combined with mycophenolate mofetil in liver transplant patients with chronic renal dysfunction

Pusen Wang, Weitao Que, Hao Li, Lvnan Yan, Zhiren Fu, Qifa Ye, Guihua Chen, Kefeng Dou, Shichun Lu, Zhanyu Yang, Zhijun Zhu, Zhihai Peng and Lin Zhong _

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Oncotarget. 2017; 8:57505-57515. https://doi.org/10.18632/oncotarget.15490

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Abstract

Pusen Wang1,*, Weitao Que1,*, Hao Li1,*, Lvnan Yan2, Zhiren Fu3, Qifa Ye4, Guihua Chen5, Kefeng Dou6, Shichun Lu7, Zhanyu Yang8, Zhijun Zhu9, Zhihai Peng1 and Lin Zhong1

1 Department of General Surgery, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

2 Department of Liver Surgery and Liver Transplantation Center, West China Hospital, Sichuan University, Chengdu, China

3 Organ Transplantation Institute of Changzheng Hospital, Second Military Medical University, Shanghai, China

4 Engineering and Technology Research Center for Transplantation Medicine of the National Ministry of Health, The Third Xiangya Hospital, Central South University, Changsha, China

5 Department of Liver Transplantation, Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

6 Department of Hepatobiliary Surgery, Xijing Hospital, The Fourth Military Medical University, Xian, China

7 Department of Liver Transplantation, Beijing Youan Hospital, Capital Medical University, Beijing, China

8 Department of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University, Chongqing, China

9 Department of Transplantation, Tianjin First Central Hospital, Tianjin Medical University, Tianjin, China

* These authors have contributed equally to this work

Correspondence to:

Lin Zhong, email:

Zhihai Peng, email:

Keywords: calcineurin inhibitors, mycophenolate mofetil, liver transplantation, efficacy, safety

Received: December 28, 2016 Accepted: February 08, 2017 Published: February 18, 2017

Abstract

Calcineurin inhibitors (CNIs) are frequently given at a reduced dose in combination with mycophenolate mofetil (MMF) to avoid nephrotoxicity, but the optimal reduction in CNI dose has not been established. In this prospective, open-label, multicenter study, liver transplant recipients with chronic renal dysfunction who were administered a CNI-based immunosuppressive regimen were included in the intent-to-treat (ITT) population. The primary endpoint was declination in renal function, which was defined as a ≥ 20% decrease in the glomerular filtration rate during the year following regimen adjustment. In the ITT population, renal function declined after regimen adjustment in three patients (7%) in the MMF plus 50% CNI reduction group. Additionally, three of 40 patients (7.5%) in the MMF plus 75% CNI reduction group experienced at least one clinically suspected or biopsy-proven acute rejection. There were no differences between the two groups. The corrected mean improvement in creatinine clearance at week 52 was 6.551 mL/min in the MMF plus 50% CNI reduction group and 6.442 mL/min in the MMF plus at least 75% CNI reduction group. Thus, a regimen of MMF combined with a 50% or at least 70% reduction in CNI dose could improve renal function and was both tolerable and safe.


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