A Phase 2 interventional study of Topiroxostat BID, (Oral daily dosing for 28 weeks) and Placebo BID, (Oral daily dosing for 28 weeks) in Diabetic Nephropathy, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-04-12.
Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout. Participants are randomized to placebo (n=20) or topiroxostat (n=40) for 28 weeks. The investigational drugs for this study are supplied by FUJI YAKUHIN CO., LTD.
543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Sanwa Kagaku Kenkyusho Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topiroxostat, (Oral daily dosing for 28 weeks)
Drug: Topiroxostat BID, (Oral daily dosing for 28 weeks)
Placebo, (Oral daily dosing for 28 weeks)
Drug: Placebo BID, (Oral daily dosing for 28 weeks)
The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.
Subjects randomized to the placebo arm will receive placebo.
Change from baseline in urine albumin creatinine ratio
Time frame: 28 weeks
sUA, eGFR, L-FABP, HbA1c, SBP, DBP, TC
Time frame: 28 weeks
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Sanwa Kagaku Kenkyusho Co., Ltd.