NCT02517320
Completed
Phase 2
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
ConditionsDiabetic Nephropathy
Overview
- Phase
- Phase 2
- Intervention
- MT-3995 Low
- Conditions
- Diabetic Nephropathy
- Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Enrollment
- 293
- Locations
- 1
- Primary Endpoint
- Change form baseline in UACR
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
MT-3995 Low
Intervention: MT-3995 Low
MT-3995 Middle
Intervention: MT-3995 Middle
MT-3995 High
Intervention: MT-3995 High
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change form baseline in UACR
Time Frame: Week 24
Secondary Outcomes
- Change in renal function(From baseline to 24 weeks)
- Change in serum potassium(From baseline to 24 weeks)
- Change in UACR classification(From baseline to 24 weeks)
- Adverse events(From baseline to 24 weeks)
Study Sites (1)
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