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

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: MT-3995 Low; Drug: MT-3995 High; Drug: Placebo; Drug: MT-3995 Middle

• Registration Number: NCT02517320
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-07
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 293

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MT-3995 Low	MT-3995 Low	-
MT-3995 High	MT-3995 High	-
Placebo	Placebo	-
MT-3995 Middle	MT-3995 Middle	-

Primary Outcome Measures

Name	Time	Method
Change form baseline in UACR	Week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Hokkaido, Japan