Publication: Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results
Issued Date
2020-02-01
Resource Type
ISSN
17449987
17449979
17449979
Other identifier(s)
2-s2.0-85077222684
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Mahidol University
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SCOPUS
Bibliographic Citation
Therapeutic Apheresis and Dialysis. Vol.24, No.1 (2020), 42-55
Suggested Citation
Hidetomo Nakamoto, Xue Qing Yu, Suhnggwon Kim, Hideki Origasa, Hongguang Zheng, Jianghua Chen, Kwon Wook Joo, Suchai Sritippayawan, Qinkai Chen, Hung Chun Chen, Yoshiharu Tsubakihara, Hirofumi Tamai, Sang Heon Song, Indralingam Vaithilingam, Kang Wook Lee, Kuo Hsiung Shu, Stanley Hok-King Lo, Masanao Isono, Hajimu Kurumatani, Kiyonobu Okada, Hiroyuki Kanoh, Takashi Kiriyama, Shunsuke Yamada, Toshiro Fujita Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results. Therapeutic Apheresis and Dialysis. Vol.24, No.1 (2020), 42-55. doi:10.1111/1744-9987.12840 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/49636
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Title
Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results
Author(s)
Hidetomo Nakamoto
Xue Qing Yu
Suhnggwon Kim
Hideki Origasa
Hongguang Zheng
Jianghua Chen
Kwon Wook Joo
Suchai Sritippayawan
Qinkai Chen
Hung Chun Chen
Yoshiharu Tsubakihara
Hirofumi Tamai
Sang Heon Song
Indralingam Vaithilingam
Kang Wook Lee
Kuo Hsiung Shu
Stanley Hok-King Lo
Masanao Isono
Hajimu Kurumatani
Kiyonobu Okada
Hiroyuki Kanoh
Takashi Kiriyama
Shunsuke Yamada
Toshiro Fujita
Xue Qing Yu
Suhnggwon Kim
Hideki Origasa
Hongguang Zheng
Jianghua Chen
Kwon Wook Joo
Suchai Sritippayawan
Qinkai Chen
Hung Chun Chen
Yoshiharu Tsubakihara
Hirofumi Tamai
Sang Heon Song
Indralingam Vaithilingam
Kang Wook Lee
Kuo Hsiung Shu
Stanley Hok-King Lo
Masanao Isono
Hajimu Kurumatani
Kiyonobu Okada
Hiroyuki Kanoh
Takashi Kiriyama
Shunsuke Yamada
Toshiro Fujita
Other Contributor(s)
Anjo Kosei Hospital
Shenyang General Hospital of PLA
Kaohsiung Medical University Chung-Ho Memorial Hospital
University of Tokyo
Chungnam National University
University of Toyama
Seoul National University Hospital
Saitama Medical University
Toray Industries, Inc.
Astellas Pharma Inc., Japan
Faculty of Medicine, Siriraj Hospital, Mahidol University
Nanchang University
Veterans General Hospital-Taichung Taiwan
Pusan National University, College of Medicine
Zhejiang University
Pamela Youde Nethersole Eastern Hospital
Jikei Institute
Hospital Taiping
Sun Yat-sen University
Shenyang General Hospital of PLA
Kaohsiung Medical University Chung-Ho Memorial Hospital
University of Tokyo
Chungnam National University
University of Toyama
Seoul National University Hospital
Saitama Medical University
Toray Industries, Inc.
Astellas Pharma Inc., Japan
Faculty of Medicine, Siriraj Hospital, Mahidol University
Nanchang University
Veterans General Hospital-Taichung Taiwan
Pusan National University, College of Medicine
Zhejiang University
Pamela Youde Nethersole Eastern Hospital
Jikei Institute
Hospital Taiping
Sun Yat-sen University
Abstract
© 2019 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy TRK-100STP, a sustained-release preparation of the orally active prostacyclin analogue beraprost sodium, targets renal hypoxia. This study aimed to show the superiority of TRK-100STP over placebos in patients with chronic kidney disease (with either primary glomerular disease or nephrosclerosis) to determine the recommended dose. CASSIOPEIR (Chronic Renal Failure Asian Study with Oral PGI2 Derivative for Evaluating Improvement of Renal Function) was a randomized, double-blind, placebo-controlled study conducted at 160 sites in seven Asia-Pacific countries and regions. Eligible patients (n = 892) were randomized to TRK-100STP 120, 240 μg, or placebo for a treatment period of up to 4 years. The primary efficacy endpoint was time to first occurrence of a renal composite: doubling of serum creatinine or occurrence of end-stage renal disease. No significant differences were observed in composite endpoints between TRK-100STP and placebo (P = 0.5674). Hazard ratios (95% CI) in the TRK-100STP 120 and 240 μg vs. placebo groups were 0.98 (0.78, 1.22) and 0.91 (0.72, 1.14), respectively. The overall incidence of adverse events and adverse drug reactions was comparable between treatment arms.