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Randomized control trial for the assessment of the anti-albuminuric effects of
topiroxostat in hyperuricemic patients with diabetic nephropathy (the ETUDE
study)
#MMPMID27303100
Kato S
; Ando M
; Mizukoshi T
; Nagata T
; Katsuno T
; Kosugi T
; Tsuboi N
; Maruyama S
Nagoya J Med Sci
2016[May]; 78
(2
): 135-42
PMID27303100
show ga
Proteinuria is an established risk factor for diabetic nephropathy. Recent
studies indicate that some xanthine oxidase inhibitors have a renoprotective
effect. The aim of this study was to assess whether topiroxostat reduces
albuminuria in hyperuricemic patients with diabetic nephropathy and overt
proteinuria. The ETUDE study is an ongoing 24-week, multicenter, open-label,
randomized (1:1), parallel group study involving hyperuricemic patients with
diabetic nephropathy (estimated glomerular filtration rate [eGFR] ? 20
mL/min/1.73 m(2)) and overt proteinuria (0.3 ? urine protein to creatinine ratio
(UPCR) < 3.5 g/g Cr). Patients are randomly assigned to high dose (topiroxostat
160 mg daily) or low dose (topiroxostat 40 mg daily) on top of standard of care.
The primary endpoint is the change in albuminuria indicated by urine
albumin-to-creatinine ratio after 24 treated weeks relative to the baseline
values. This trial was registered at the Japanese University Hospital Medical
Information Network Clinical Trials Registry (UMIN-CTR: UMIN 000015403). The
background, rationale, and study design of this trial are presented here.
Seventy-six patients from four registered facilities have already been enrolled
and received at least one dose of topiroxostat. This trial will end in 2017. The
ETUDE trial is the first randomized controlled study of topiroxostat in
hyperuricemic patients with diabetic nephropathy and overt proteinuria. We will
clarify the pleiotropic function of topiroxostat including an anti-albumiuric
effect as well as its effects on safely decreasing serum uric acid levels.