A multinational phase IIb/III trial of beraprost sodium, an orally active prostacyclin analogue, in patients with primary glomerular disease or nephrosclerosis (CASSIOPEIR trial), rationale and study design

作者：Nakamoto Hidetomo^*; Fujita Toshiro; Origasa Hideki; Isono Masanao; Kurumatani Hajimu; Okada Kiyonobu; Kanoh Hiroyuki; Kiriyama Takashi; Yamada Shunsuke

来源：BMC Nephrology, 2014, 15(1): 153.

DOI：10.1186/1471-2369-15-153

• Prostacyclin analogue
• PGI(2)
• Beraprost sodium
• Chronic kidney disease
• Primary glomerular disease
• Nephrosclerosis
• Serum creatinine
• Renal composite endpoint
• CASSIOPEIR
• TRK-100STP

Background: Chronic kidney disease (CKD) is public health concern even in Asian countries. TRK-100STP, a sustained release tablet of an orally-active prostacyclin analogue, beraprost sodium, is suggested to suppress worsening of some parameters of renal filtration function, containing in slope of 1/serum creatinine (1/SCr) vs. time in a phase II clinical trial. %26lt;br%26gt;Methods/design: We describe the design of the phase IIb/III trial of TRK-100STP, CASSIOPEIR (CRF Asian Study with Oral PGI(2) derivative for Evaluating Improvement of Renal function) conducted in approximately 160 centers in China, Hong Kong, Japan, Malaysia, Republic of Korea, Taiwan, and Thailand. A total of 750 patients (n = 250 per group) with primary glomerular disease or nephrosclerosis were planned to be enrolled. Patients were randomized into one of three treatment groups in a double-bind, placebo-controlled manner: TRK-100STP 60 mu g b.i.d.; TRK-100STP 120 mu g b.i.d.; or placebo. The treatment period is planned to last 2 to 4 years. The primary efficacy endpoint is the renal composite endpoint including doubling of SCr and ESRD (dialysis induction, renal transplantation, or increase in SCr to %26gt;= 6.0 mg/dL). %26lt;br%26gt;Discussion: This trial targeting CKD patients is designed to (a) demo

• 出版日期2014-9-19