Effects of Sustained-Release Beraprost in Patients With Primary Glomerular Disease or Nephrosclerosis: CASSIOPEIR Study Results
| Autor: | Sang Heon Song, Kwon Wook Joo, Stanley Hok-King Lo, Hajimu Kurumatani, Hongguang Zheng, Hung Chun Chen, Kiyonobu Okada, Takashi Kiriyama, Masanao Isono, Suhnggwon Kim, Indralingam Vaithilingam, Kang Wook Lee, Jianghua Chen, Shunsuke Yamada, Hidetomo Nakamoto, Hideki Origasa, Yoshiharu Tsubakihara, Suchai Sritippayawan, Kuo Hsiung Shu, Toshiro Fujita, Hirofumi Tamai, Hiroyuki Kanoh, Qinkai Chen, Xueqing Yu |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Vasodilator Agents 030232 urology & nephrology Renal function 030204 cardiovascular system & hematology Placebo Gastroenterology 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Double-Blind Method Internal medicine Medicine Humans Renal Insufficiency Chronic Adverse effect Aged Creatinine Nephrosclerosis Dose-Response Relationship Drug business.industry Hazard ratio Hematology Middle Aged medicine.disease Epoprostenol Beraprost chemistry Nephrology Delayed-Action Preparations Female business medicine.drug Kidney disease |
| Zdroj: | Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis TherapyREFERENCES. 24(1) |
| ISSN: | 1744-9987 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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