Hidetomo NakamotoXue Qing YuSuhnggwon KimHideki OrigasaHongguang ZhengJianghua ChenKwon Wook JooSuchai SritippayawanQinkai ChenHung Chun ChenYoshiharu TsubakiharaHirofumi TamaiSang Heon SongIndralingam VaithilingamKang Wook LeeKuo Hsiung ShuStanley Hok-King LoMasanao IsonoHajimu KurumataniKiyonobu OkadaHiroyuki KanohTakashi KiriyamaShunsuke YamadaToshiro FujitaAnjo Kosei HospitalShenyang General Hospital of PLAKaohsiung Medical University Chung-Ho Memorial HospitalUniversity of TokyoChungnam National UniversityUniversity of ToyamaSeoul National University HospitalSaitama Medical UniversityToray Industries, Inc.Astellas Pharma Inc., JapanFaculty of Medicine, Siriraj Hospital, Mahidol UniversityNanchang UniversityVeterans General Hospital-Taichung TaiwanPusan National University, College of MedicineZhejiang UniversityPamela Youde Nethersole Eastern HospitalJikei InstituteHospital TaipingSun Yat-sen University2020-01-272020-01-272020-02-01Therapeutic Apheresis and Dialysis. Vol.24, No.1 (2020), 42-5517449987174499792-s2.0-85077222684https://repository.li.mahidol.ac.th/handle/20.500.14594/49636© 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.Mahidol UniversityMedicineArticleSCOPUS10.1111/1744-9987.12840