Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
NCT ID: NCT02517320
Last Updated: 2017-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
293 participants
INTERVENTIONAL
2015-07-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MT-3995 Low
MT-3995 Low
MT-3995 Middle
MT-3995 Middle
MT-3995 High
MT-3995 High
Placebo
Placebo
Interventions
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MT-3995 Low
MT-3995 Middle
MT-3995 High
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
75 Years
ALL
No
Sponsors
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Mitsubishi Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Locations
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Investigational site
Hokkaido, , Japan
Countries
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References
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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.
Other Identifiers
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MT-3995-J05
Identifier Type: -
Identifier Source: org_study_id
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