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Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial.

ABSTRACT: Evidence increasingly points to the importance of chronic hypoxia in the tubulointerstitium as a final common pathway to end-stage renal disease (ESRD). Beraprost sodium (BPS) is an orally active prostacyclin (PGI2) analogue demonstrating prevention of the progression of chronic kidney disease (CKD) in various animal models by maintaining renal blood flow and attenuating renal ischemic condition.This multicenter, randomized, double-blind, placebo-controlled, phase II trial was designed to determine the recommended dose of the sustained-release form of BPS (TRK-100STP 120 ?g/day or 240 ?g/day) in Japanese patients with CKD. TRK-100STP was administered to a total of 112 patients. The primary efficacy endpoint was the difference in the slope of the regression line of reciprocal of serum creatinine (1/SCr) over time, obtained by the least-squares method.Regarding the primary endpoint, statistical superiority of TRK-100STP 240 ?g over placebo was not confirmed and so a recommended dose was not determined. Compared to placebo, however, the slope of regression line of 1/SCr, elevation of SCr and serum cystatin C during the treatment period revealed greater improvement at 120 ?g, at both doses, and at 240 ?g, respectively. In terms of safety, both TRK-100STP treatment groups were well tolerated.Although the study failed to meet the primary endpoint, results indicate that TRK-100STP may potentially prevent the decline in renal function of CKD patients independent of blood pressure or urinary protein levels.NCT02480751. June 21, 2015.

SUBMITTER: Koyama A

PROVIDER: S-EPMC4608181 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature

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Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial.

Koyama Akio A Fujita Toshiro T Gejyo Fumitake F Origasa Hideki H Isono Masanao M Kurumatani Hajimu H Okada Kiyonobu K Kanoh Hiroyuki H Kiriyama Takashi T Yamada Shunsuke S

BMC nephrology 20151016

<h4>Background</h4>Evidence increasingly points to the importance of chronic hypoxia in the tubulointerstitium as a final common pathway to end-stage renal disease (ESRD). Beraprost sodium (BPS) is an orally active prostacyclin (PGI2) analogue demonstrating prevention of the progression of chronic kidney disease (CKD) in various animal models by maintaining renal blood flow and attenuating renal ischemic condition.<h4>Methods</h4>This multicenter, randomized, double-blind, placebo-controlled, ph ...[more]

PMID: 26475266

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Dataset Information

Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial.

Publications

Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial.

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