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 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.
['Nakamoto|Hidetomo|H|https://orcid.org/0000-0003-3975-5067', 'Yu|Xue-Qing|XQ|', 'Kim|Suhnggwon|S|', 'Origasa|Hideki|H|', 'Zheng|Hongguang|H|', 'Chen|Jianghua|J|', 'Joo|Kwon Wook|KW|', 'Sritippayawan|Suchai|S|', 'Chen|Qinkai|Q|', 'Chen|Hung-Chun|HC|', 'Tsubakihara|Yoshiharu|Y|', 'Tamai|Hirofumi|H|', 'Song|Sang Heon|SH|', 'Vaithilingam|Indralingam|I|', 'Lee|Kang Wook|KW|', 'Shu|Kuo-Hsiung|KH|', 'Hok-King Lo|Stanley|S|', 'Isono|Masanao|M|', 'Kurumatani|Hajimu|H|https://orcid.org/0000-0002-9459-9362', 'Okada|Kiyonobu|K|', 'Kanoh|Hiroyuki|H|', 'Kiriyama|Takashi|T|', 'Yamada|Shunsuke|S|', 'Fujita|Toshiro|T|']
D000328:Adult D000368:Aged D003404:Creatinine D003692:Delayed-Action Preparations D004305:Dose-Response Relationship, Drug D004311:Double-Blind Method D011464:Epoprostenol D005260:Female D006801:Humans D008297:Male D008875:Middle Aged D009400:Nephrosclerosis D051436:Renal Insufficiency, Chronic D014665:Vasodilator Agents D055815:Young Adult
Beraprost CASSIOPEIR TRK-100STP Prostacyclin Chronic kidney disease