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

Nakamoto H 1 , Yu XQ 2 , Kim S 3 , Origasa H 4 , Zheng H 5 , Chen J 6 Show all authors , Joo KW 7 , Sritippayawan S 8 , Chen Q 9 , Chen HC 10 , Tsubakihara Y 11 , Tamai H 12 , Song SH 13 , Vaithilingam I 14 , Lee KW 15 , Shu KH 16 , Hok-King Lo S 17 , Isono M 18 , Kurumatani H 18 , Okada K 18 , Kanoh H 19 , Kiriyama T 19 , Yamada S 19 , Fujita T 20

Affiliations 

  • 1 Saitama Medical University, Saitama, Japan
  • 2 The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou City, China
  • 3 Seoul National University Hospital, Seoul K Clinic, Seoul, South Korea
  • 4 The University of Toyama, Toyama, Japan
  • 5 The General Hospital of Shenyang Military Command, Shenyang City, China
  • 6 The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
  • 7 Seoul National University Hospital, Seoul, South Korea
  • 8 Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 9 The First Affiliated Hospital of Nanchang University, Nanchang, China
  • 10 Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan
  • 11 Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan
  • 12 Anjo Kosei Hospital, Aichi, Japan
  • 13 Pusan National University Hospital, Busan, South Korea
  • 14 Hospital Taiping, Perak, Malaysia
  • 15 Department of Internal Medicine, Chungnam National University Hospital, Daejeon, South Korea
  • 16 Taichung Veterans General Hospital, Taichung, Taiwan
  • 17 Department of Medicine, Pamela Youde Nethersole Eastern Hospital, Chai Wan, Hong Kong
  • 18 Toray Industries, Inc., Tokyo, Japan
  • 19 Astellas Pharma Inc., Tokyo, Japan
  • 20 The University of Tokyo, Tokyo, Japan
Ther Apher Dial, 2020 Feb;24(1):42-55.
PMID: 31119846 DOI: 10.1111/1744-9987.12840

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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