Back to resultsEfficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathy
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
MT-3995 Low
MT-3995 Middle
MT-3995 High
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy
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
Sites / Locations
- Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
MT-3995 Low
MT-3995 Middle
MT-3995 High
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change form baseline in UACR
Secondary Outcome Measures
Change in UACR classification
Change in renal function
Change in serum potassium
Adverse events
Full Information
NCT ID
NCT02517320
First Posted
August 4, 2015
Last Updated
March 1, 2017
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02517320
Brief Title
Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MT-3995 Low
Arm Type
Experimental
Arm Title
MT-3995 Middle
Arm Type
Experimental
Arm Title
MT-3995 High
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MT-3995 Low
Intervention Type
Drug
Intervention Name(s)
MT-3995 Middle
Intervention Type
Drug
Intervention Name(s)
MT-3995 High
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change form baseline in UACR
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change in UACR classification
Time Frame
From baseline to 24 weeks
Title
Change in renal function
Time Frame
From baseline to 24 weeks
Title
Change in serum potassium
Time Frame
From baseline to 24 weeks
Title
Adverse events
Time Frame
From baseline to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Investigational site
City
Hokkaido
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
32974732
Citation
Wada T, Inagaki M, Yoshinari T, Terata R, Totsuka N, Gotou M, Hashimoto G. Apararenone in patients with diabetic nephropathy: results of a randomized, double-blind, placebo-controlled phase 2 dose-response study and open-label extension study. Clin Exp Nephrol. 2021 Feb;25(2):120-130. doi: 10.1007/s10157-020-01963-z. Epub 2020 Sep 24.
Results Reference
derived
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Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
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