Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
1 other identifier
interventional
293
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2015
CompletedFirst Posted
Study publicly available on registry
August 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMarch 3, 2017
March 1, 2017
1.3 years
August 4, 2015
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change form baseline in UACR
Week 24
Secondary Outcomes (4)
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
Study Arms (4)
MT-3995 Low
EXPERIMENTALMT-3995 Middle
EXPERIMENTALMT-3995 High
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Investigational site
Hokkaido, Japan
Related Publications (1)
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.
PMID: 32974732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2015
First Posted
August 7, 2015
Study Start
July 1, 2015
Primary Completion
November 1, 2016
Study Completion
January 1, 2017
Last Updated
March 3, 2017
Record last verified: 2017-03