Effects of Sustained‐Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results
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...
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| creator | 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 |
| description | 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. |
| doi_str_mv | 10.1111/1744-9987.12840 |
| format | Article |
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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.</description><identifier>ISSN: 1744-9979</identifier><identifier>EISSN: 1744-9987</identifier><identifier>DOI: 10.1111/1744-9987.12840</identifier><identifier>PMID: 31119846</identifier><language>eng</language><publisher>Kyoto, Japan: John Wiley & Sons Australia, Ltd</publisher><subject>Beraprost ; CASSIOPEIR ; Chronic kidney disease ; Prostacyclin ; TRK‐100STP</subject><ispartof>Therapeutic apheresis and dialysis, 2020-02, Vol.24 (1), p.42-55</ispartof><rights>2019 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy</rights><rights>2019 International Society for Apheresis, Japanese Society for Apheresis, and Japanese Society for Dialysis Therapy.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4080-a3a1e20a5be16f2be5281a2077332ef54a30855b35ed1a0379d3ba97f62751483</citedby><cites>FETCH-LOGICAL-c4080-a3a1e20a5be16f2be5281a2077332ef54a30855b35ed1a0379d3ba97f62751483</cites><orcidid>0000-0002-9459-9362 ; 0000-0003-3975-5067</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2F1744-9987.12840$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2F1744-9987.12840$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31119846$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakamoto, Hidetomo</creatorcontrib><creatorcontrib>Yu, Xue‐Qing</creatorcontrib><creatorcontrib>Kim, Suhnggwon</creatorcontrib><creatorcontrib>Origasa, Hideki</creatorcontrib><creatorcontrib>Zheng, Hongguang</creatorcontrib><creatorcontrib>Chen, Jianghua</creatorcontrib><creatorcontrib>Joo, Kwon Wook</creatorcontrib><creatorcontrib>Sritippayawan, Suchai</creatorcontrib><creatorcontrib>Chen, Qinkai</creatorcontrib><creatorcontrib>Chen, Hung‐Chun</creatorcontrib><creatorcontrib>Tsubakihara, Yoshiharu</creatorcontrib><creatorcontrib>Tamai, Hirofumi</creatorcontrib><creatorcontrib>Song, Sang Heon</creatorcontrib><creatorcontrib>Vaithilingam, Indralingam</creatorcontrib><creatorcontrib>Lee, Kang Wook</creatorcontrib><creatorcontrib>Shu, Kuo‐Hsiung</creatorcontrib><creatorcontrib>Hok‐King Lo, Stanley</creatorcontrib><creatorcontrib>Isono, Masanao</creatorcontrib><creatorcontrib>Kurumatani, Hajimu</creatorcontrib><creatorcontrib>Okada, Kiyonobu</creatorcontrib><creatorcontrib>Kanoh, Hiroyuki</creatorcontrib><creatorcontrib>Kiriyama, Takashi</creatorcontrib><creatorcontrib>Yamada, Shunsuke</creatorcontrib><creatorcontrib>Fujita, Toshiro</creatorcontrib><title>Effects of Sustained‐Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results</title><title>Therapeutic apheresis and dialysis</title><addtitle>Ther Apher Dial</addtitle><description>TRK‐100STP, a sustained‐release preparation of the orally active prostacyclin analogue beraprost sodium, targets renal hypoxia. 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The overall incidence of adverse events and adverse drug reactions was comparable between treatment arms.</description><subject>Beraprost</subject><subject>CASSIOPEIR</subject><subject>Chronic kidney disease</subject><subject>Prostacyclin</subject><subject>TRK‐100STP</subject><issn>1744-9979</issn><issn>1744-9987</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNqFkE9PwjAchhujEUTP3kyPXoD-2V9viIgkRAjDeGy67bdQ0zFctxhu-g38jH4SC0Ou9tA2zfO-6e9B6JqSHrWrT33H6YZh4PcoCxxygtrHl9Pj3Q9b6MKYN0IYczg_Ry1us2HgeG30NcoySCqDiwxHtamkWkP68_m9AA3SAL6HUm7KwlRYrfFcVgrWFn5V1QrPS5XLcovHusihrLUs8YMy-1RR4mfYrGwu0WB3Ze7wcBBFk9l8NFngqKrTLV6AqXVlLtFZJrWBq8PZQS-Po-XwqTudjSfDwbSbOCQgXcklBUakGwP1MhaDywIqGfF9zhlkriM5CVw35i6kVBLuhymPZehnHvNd6gS8g26bXjvOew2mErkyCWgt11DURjDGGSUe87hF-w2a2L-bEjKxaWYVlIidd7EzK3aWxd67Tdwcyus4h_TI_4m2gNsAH0rD9r8-sRzMm-JfffGN-w</recordid><startdate>202002</startdate><enddate>202002</enddate><creator>Nakamoto, Hidetomo</creator><creator>Yu, Xue‐Qing</creator><creator>Kim, Suhnggwon</creator><creator>Origasa, Hideki</creator><creator>Zheng, Hongguang</creator><creator>Chen, Jianghua</creator><creator>Joo, Kwon Wook</creator><creator>Sritippayawan, Suchai</creator><creator>Chen, Qinkai</creator><creator>Chen, Hung‐Chun</creator><creator>Tsubakihara, Yoshiharu</creator><creator>Tamai, Hirofumi</creator><creator>Song, Sang Heon</creator><creator>Vaithilingam, Indralingam</creator><creator>Lee, Kang Wook</creator><creator>Shu, Kuo‐Hsiung</creator><creator>Hok‐King Lo, Stanley</creator><creator>Isono, Masanao</creator><creator>Kurumatani, Hajimu</creator><creator>Okada, Kiyonobu</creator><creator>Kanoh, Hiroyuki</creator><creator>Kiriyama, Takashi</creator><creator>Yamada, Shunsuke</creator><creator>Fujita, Toshiro</creator><general>John Wiley & Sons Australia, Ltd</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-9459-9362</orcidid><orcidid>https://orcid.org/0000-0003-3975-5067</orcidid></search><sort><creationdate>202002</creationdate><title>Effects of Sustained‐Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4080-a3a1e20a5be16f2be5281a2077332ef54a30855b35ed1a0379d3ba97f62751483</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Beraprost</topic><topic>CASSIOPEIR</topic><topic>Chronic kidney disease</topic><topic>Prostacyclin</topic><topic>TRK‐100STP</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakamoto, Hidetomo</creatorcontrib><creatorcontrib>Yu, Xue‐Qing</creatorcontrib><creatorcontrib>Kim, Suhnggwon</creatorcontrib><creatorcontrib>Origasa, Hideki</creatorcontrib><creatorcontrib>Zheng, Hongguang</creatorcontrib><creatorcontrib>Chen, Jianghua</creatorcontrib><creatorcontrib>Joo, Kwon Wook</creatorcontrib><creatorcontrib>Sritippayawan, Suchai</creatorcontrib><creatorcontrib>Chen, Qinkai</creatorcontrib><creatorcontrib>Chen, Hung‐Chun</creatorcontrib><creatorcontrib>Tsubakihara, Yoshiharu</creatorcontrib><creatorcontrib>Tamai, Hirofumi</creatorcontrib><creatorcontrib>Song, Sang Heon</creatorcontrib><creatorcontrib>Vaithilingam, Indralingam</creatorcontrib><creatorcontrib>Lee, Kang Wook</creatorcontrib><creatorcontrib>Shu, Kuo‐Hsiung</creatorcontrib><creatorcontrib>Hok‐King Lo, Stanley</creatorcontrib><creatorcontrib>Isono, Masanao</creatorcontrib><creatorcontrib>Kurumatani, Hajimu</creatorcontrib><creatorcontrib>Okada, Kiyonobu</creatorcontrib><creatorcontrib>Kanoh, Hiroyuki</creatorcontrib><creatorcontrib>Kiriyama, Takashi</creatorcontrib><creatorcontrib>Yamada, Shunsuke</creatorcontrib><creatorcontrib>Fujita, Toshiro</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Therapeutic apheresis and dialysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Nakamoto, Hidetomo</au><au>Yu, Xue‐Qing</au><au>Kim, Suhnggwon</au><au>Origasa, Hideki</au><au>Zheng, Hongguang</au><au>Chen, Jianghua</au><au>Joo, Kwon Wook</au><au>Sritippayawan, Suchai</au><au>Chen, Qinkai</au><au>Chen, Hung‐Chun</au><au>Tsubakihara, Yoshiharu</au><au>Tamai, Hirofumi</au><au>Song, Sang Heon</au><au>Vaithilingam, Indralingam</au><au>Lee, Kang Wook</au><au>Shu, Kuo‐Hsiung</au><au>Hok‐King Lo, Stanley</au><au>Isono, Masanao</au><au>Kurumatani, Hajimu</au><au>Okada, Kiyonobu</au><au>Kanoh, Hiroyuki</au><au>Kiriyama, Takashi</au><au>Yamada, Shunsuke</au><au>Fujita, Toshiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of Sustained‐Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results</atitle><jtitle>Therapeutic apheresis and dialysis</jtitle><addtitle>Ther Apher Dial</addtitle><date>2020-02</date><risdate>2020</risdate><volume>24</volume><issue>1</issue><spage>42</spage><epage>55</epage><pages>42-55</pages><issn>1744-9979</issn><eissn>1744-9987</eissn><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.</abstract><cop>Kyoto, Japan</cop><pub>John Wiley & Sons Australia, Ltd</pub><pmid>31119846</pmid><doi>10.1111/1744-9987.12840</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0002-9459-9362</orcidid><orcidid>https://orcid.org/0000-0003-3975-5067</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Beraprost CASSIOPEIR Chronic kidney disease Prostacyclin TRK‐100STP |
| title | Effects of Sustained‐Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results |
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