Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: MT-3995 Low
* Drug: MT-3995 Middle
* Drug: MT-3995 High
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-3995 Low<br> | Drug: MT-3995 Low<br> <br> |
| Experimental: MT-3995 Middle<br> | Drug: MT-3995 Middle<br> <br> |
| Experimental: MT-3995 High<br> | Drug: MT-3995 High<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change form baseline in UACR |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Nephropathy