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2015 ; 16
(ä): 165
Nephropedia Template TP
gab.com Text
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English Wikipedia
Orally active prostacyclin analogue beraprost sodium in patients with chronic
kidney disease: a randomized, double-blind, placebo-controlled, phase II dose
finding trial
#MMPMID26475266
Koyama A
; Fujita T
; Gejyo F
; Origasa H
; Isono M
; Kurumatani H
; Okada K
; Kanoh H
; Kiriyama T
; Yamada S
BMC Nephrol
2015[Oct]; 16
(ä): 165
PMID26475266
show ga
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: NCT02480751. June 21, 2015.