Kidney Week

Abstract: TH-PO1165

Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Combination with Calcineurin Inhibitors in Chinese Renal Transplant Recipients: An Observational Phase 4 Study

Session Information

• Late-Breaking Clinical Trials Posters
  October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Transplantation

• No subcategory defined

Authors

• Shi, Bingyi, 309th Hospital of PLA, Beijing, China

Bingyi Shi,

• Wang, Changxi, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China

Changxi Wang,

• Lin, Tao, West China Hospital, Sichuan University, Chengdu, Sichuan Province, China

Tao Lin,

• Zhang, Aimin, General Hospital of Jinan Military Region of PLA, Jinan, China

Aimin Zhang,

• Men, Tongyi, Shandong Qianfoshan Hospital, China, Xian, China

Tongyi Men,

• Yuan, Jianlin, Xijing Hospital affiliated to Fourth Military Medical University, China, Xi’an, China

Jianlin Yuan,

• Pan, Guanghui, The Second Affiliated Hospital of GuangZhou Medical College, China, Guangzhou, China

Guanghui Pan,

• Xu, Da, Ruijin Hospital affiliated to Shanghai Jiao Tong University, China, Shanghai, China

Da Xu,

• Wu, Xiaotong, The Second People''s Hospital of Shanxi Province, China, Taiyuan, China

Xiaotong Wu,

• Xie, Jinliang, XiangYa Hospital Central-South University, Changsha, China

Jinliang Xie,

• Chen, Jianghua, The First Affiliated Hospital of Medical School of Zhejiang, Zhejiang University, Hangzhou, ZheJiang, China

Jianghua Chen,

• Mo, Chunbai, Tianjin First Center Hospital, China, Tianjin, China

Chunbai Mo,

• Cheng, Ke, The Third Xiangya Hospital of Central South University, China, Changsha, China

Ke Cheng,

• Guo, Hongxin, 463rd Hospital of PLA, China, Shenyang, China

Hongxin Guo,

• Zhang, Xiaodong, Beijing Chao-Yang Hospital, China, Beijing, China

Xiaodong Zhang,

• Gu, Xiaowen, Novartis China, Shanghai, China

Xiaowen Gu,

• Meier, Matthias, Novartis Pharma, Basel, Switzerland

Matthias Meier,

Background

This phase IV observational study (ERL080A2424) compared efficacy and safety of enteric coated mycophenolate sodium (EC-MPS; myfortic^®) vs mycophenolate mofetil (MMF; Cellcept^®) in Chinese renal transplant recipients (RTxR).

Methods

In this 12-month (M) study, 600 adult RTxR received EC-MPS (N=401) or MMF (N=199) + cyclosporine(CsA)/tacrolimus(TAC) + steroids post-Tx. Usage of mycophenolic acid (MPA) dosing regimen, efficacy, and safety at M12, and MPA exposure (AUC_0-12h; EC-MPS) in a pharmacokinetic (PK) subset at days 14 and 90 post-Tx were assessed.

Results

Most patients in EC-MPS (78.4%) and MMF (87.8%) cohorts received a starting daily dose ±25% of recommended dose (EC-MPS: 1440 mg/day; MMF: 2000 mg/day). Efficacy events were similar in both cohorts (Table 1). Patients receiving lowest range of starting daily doses (EC-MPS: 360-<720 mg; MMF: 500-<1000 mg) had numerically higher acute rejection (AR) rates than patients with higher MPA exposure (EC-MPS, P=0.200; MMF, P=0.670). MPA exposure (AUC_0-12h; EC-MPS) increased in CsA subset from days 14 to 90, but was similar in TAC subset (Table 2). Probability of developing serious infections was low with starting doses ±25% of recommended dose for both cohorts.

Conclusion

EC-MPS and MMF cohorts showed similar efficacy and safety at M12; lowest dose ranges, but not higher, were associated with AR rates in EC-MPS cohort. These results will facilitate informed decision-making for EC-MPS-based regimen in China and for patients of Chinese ethnicity in the US.

Funding

• Commercial Support – Novartis