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