A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria

Study Overview
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Brief Summary
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The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria

Official Title
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A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2

Conditions
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Diabetic Nephropathy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB) Glycosylated haemoglobin (HbA1c) ≤10.5% An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m^2 Subject with albuminuria Exclusion Criteria: History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy Serum potassium level <3.5 or >5.0 mmol/L Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation Subjects with a history of renal transplant Subjects with clinically significant hypotension

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-3995 Low group<br> | Drug: MT-3995 Low<br>* MT-3995 Low dose for 8 weeks<br>|
| Experimental: MT-3995 High group<br> | Drug: MT-3995 High<br>* MT-3995 High dose for 8 weeks<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* Placebo for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. |  | up to 8 weeks | 
| Frequency and nature of treatment-emergent adverse events and serious adverse events. |  | up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in UACR compared to placebo |  | up to 8 weeks | 
| Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group. |  | up to 8 weeks | 
| Plasma concentrations of MT-3995 and its major metabolite |  | up to 16 weeks | 

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