Diabetic nephropathy with hyperuricemia
Conditions
Interventions
High dose of Topiroxostat
Low dose of Topiroxostat
Sponsors
Department of Nephrology, Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Diabetes mellitus 2 Hyperuricemia 3 0.3 <= UPCR < 3.5g/gCr and eGFR >= 20 mL/min/1.73m2 4 Patients with under diet threrapy and exercise therapy 8 weeeks before enrollment 5 <= 20 years old 6 Patients who are able to write informed consent 7 Outpatient
Exclusion criteria
Exclusion criteria: 1 Poor diabetic control 2 Patient have been treated with steroids 3 Patient with nephropathy excluding diabetic nephropathy (including: nephrosclerosis) 4 Cancer 5 Systemic disease with proteinuria (collagen disease, vasculitis and amyloidosis) 6 Gouty arthritis within 6 months 7 ALT, AST >= double as the standard of each hospital 8 Active Hepatitis C and/or C 9 Liver cirrhosis 10 Patients are deemed unsuitable by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in urinary albumin level at 24 weeks after administration using the urinary albumin level before administration at the benchmark | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change in urinary protein creatinine ratio -Change in blood pressure (SBP, DBP) at outpatients clinic -Change in HbA1c (NGSP) -Change in eGFR -Change in serum uric acid -Change in urinary L-FABP -Safety evaluation: adverse events | — |
Countries
Japan
Contacts
Public ContactSawako Kato
Nagoya University Graduate School of Medicine Nephrology
Outcome results
None listed