Diabetic Nephropathy
Conditions
Keywords
Diabetic Nephropathy
Brief summary
The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5% * estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2 * The median UACR of the first morning void urine samples is ≥50 mg/g Cr and \<300 mg/g Cr * Stable blood pressure(diastolic blood pressure (DBP) \<100 mmHg and stable systolic blood pressure (SBP) \<160 mmHg)
Exclusion criteria
* Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes. * A diagnosis of non-diabetic renal disease. * A following serum potassium level. * eGFR of 30-59mL/min/1.73m2; serum potassium level of \<3.5 or \>4.7 mmol/L, * eGFR of ≥60mL/min/1.73m2: serum potassium level of \<3.5 or \>5.0 mmol/L * symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)\<50mmHg and systolic blood pressure(SBP)\<110mmHg) * QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes * New York Heart Association (NYHA) Class III or IV heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change form baseline in UACR | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change in UACR classification | From baseline to 24 weeks |
| Change in renal function | From baseline to 24 weeks |
| Change in serum potassium | From baseline to 24 weeks |
| Adverse events | From baseline to 24 weeks |
Countries
Japan
Outcome results
None listed