Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results

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 OkadaHiroyuki Kanoh, Takashi Kiriyama, Shunsuke Yamada, Toshiro Fujita

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)42-55
Number of pages14
JournalTherapeutic Apheresis and Dialysis
Volume24
Issue number1
DOIs
StatePublished - 1 Feb 2020

Fingerprint

beraprost
Nephrosclerosis
Placebos
Epoprostenol
Kidney
Chronic Kidney Failure
Delayed-Action Preparations
Drug-Related Side Effects and Adverse Reactions
Chronic Renal Insufficiency
Creatinine

Keywords

  • Beraprost
  • CASSIOPEIR
  • Chronic kidney disease
  • Prostacyclin
  • TRK-100STP

Cite this

Nakamoto, Hidetomo ; Yu, Xue Qing ; Kim, Suhnggwon ; Origasa, Hideki ; Zheng, Hongguang ; Chen, Jianghua ; Joo, Kwon Wook ; Sritippayawan, Suchai ; Chen, Qinkai ; Chen, Hung Chun ; Tsubakihara, Yoshiharu ; Tamai, Hirofumi ; Song, Sang Heon ; Vaithilingam, Indralingam ; Lee, Kang Wook ; Shu, Kuo Hsiung ; Hok-King Lo, Stanley ; Isono, Masanao ; Kurumatani, Hajimu ; Okada, Kiyonobu ; Kanoh, Hiroyuki ; Kiriyama, Takashi ; Yamada, Shunsuke ; Fujita, Toshiro. / Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis : CASSIOPEIR Study Results. In: Therapeutic Apheresis and Dialysis. 2020 ; Vol. 24, No. 1. pp. 42-55.
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author = "Hidetomo Nakamoto and Yu, {Xue Qing} and Suhnggwon Kim and Hideki Origasa and Hongguang Zheng and Jianghua Chen and Joo, {Kwon Wook} and Suchai Sritippayawan and Qinkai Chen and Chen, {Hung Chun} and Yoshiharu Tsubakihara and Hirofumi Tamai and Song, {Sang Heon} and Indralingam Vaithilingam and Lee, {Kang Wook} and Shu, {Kuo Hsiung} and {Hok-King Lo}, Stanley and Masanao Isono and Hajimu Kurumatani and Kiyonobu Okada and Hiroyuki Kanoh and Takashi Kiriyama and Shunsuke Yamada and Toshiro Fujita",
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Nakamoto, H, Yu, XQ, Kim, S, Origasa, H, Zheng, H, Chen, J, Joo, KW, Sritippayawan, S, Chen, Q, Chen, HC, Tsubakihara, Y, Tamai, H, Song, SH, Vaithilingam, I, Lee, KW, Shu, KH, Hok-King Lo, S, Isono, M, Kurumatani, H, Okada, K, Kanoh, H, Kiriyama, T, Yamada, S & Fujita, T 2020, 'Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results', Therapeutic Apheresis and Dialysis, vol. 24, no. 1, pp. 42-55. https://doi.org/10.1111/1744-9987.12840

Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis : CASSIOPEIR Study Results. / Nakamoto, Hidetomo; Yu, Xue Qing; Kim, Suhnggwon; Origasa, Hideki; Zheng, Hongguang; Chen, Jianghua; Joo, Kwon Wook; Sritippayawan, Suchai; Chen, Qinkai; Chen, Hung Chun; Tsubakihara, Yoshiharu; Tamai, Hirofumi; Song, Sang Heon; Vaithilingam, Indralingam; Lee, Kang Wook; Shu, Kuo Hsiung; Hok-King Lo, Stanley; Isono, Masanao; Kurumatani, Hajimu; Okada, Kiyonobu; Kanoh, Hiroyuki; Kiriyama, Takashi; Yamada, Shunsuke; Fujita, Toshiro.

In: Therapeutic Apheresis and Dialysis, Vol. 24, No. 1, 01.02.2020, p. 42-55.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis

T2 - CASSIOPEIR Study Results

AU - Nakamoto, Hidetomo

AU - Yu, Xue Qing

AU - Kim, Suhnggwon

AU - Origasa, Hideki

AU - Zheng, Hongguang

AU - Chen, Jianghua

AU - Joo, Kwon Wook

AU - Sritippayawan, Suchai

AU - Chen, Qinkai

AU - Chen, Hung Chun

AU - Tsubakihara, Yoshiharu

AU - Tamai, Hirofumi

AU - Song, Sang Heon

AU - Vaithilingam, Indralingam

AU - Lee, Kang Wook

AU - Shu, Kuo Hsiung

AU - Hok-King Lo, Stanley

AU - Isono, Masanao

AU - Kurumatani, Hajimu

AU - Okada, Kiyonobu

AU - Kanoh, Hiroyuki

AU - Kiriyama, Takashi

AU - Yamada, Shunsuke

AU - Fujita, Toshiro

PY - 2020/2/1

Y1 - 2020/2/1

N2 - 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.

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KW - Beraprost

KW - CASSIOPEIR

KW - Chronic kidney disease

KW - Prostacyclin

KW - TRK-100STP

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U2 - 10.1111/1744-9987.12840

DO - 10.1111/1744-9987.12840

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