The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
NCT ID: NCT02316821
Last Updated: 2017-10-27
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
216 participants
INTERVENTIONAL
2014-12-31
2017-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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bardoxolone methyl
bardoxolone methyl capsules, dosage To Be Determined, once daily for 16 weeks
RTA 402
Placebo
Placebo capsules, once daily for 16 weeks
Placebo
Interventions
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RTA 402
Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients whose estimated GFR levels are eligible for this study
* Patients being treated with stable dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin II receptor blocker (ARB) etc.
Exclusion Criteria
* Patients with known non-diabetic renal disease
* Patients with a history of renal transplantation
* Patients with mean systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 90 mmHg
* Patients with Hemoglobin A1c \> 10%
* Patients with cardiovascular disease specified in the study protocol etc.
20 Years
79 Years
ALL
No
Sponsors
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Kyowa Kirin Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Tokyo, , Japan
Countries
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References
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Mwesigwa N, Millar Vernetti P, Kirabo A, Black B, Ding T, Martinez J, Palma JA, Biaggioni I, Kaufmann H, Shibao CA. Atomoxetine on neurogenic orthostatic hypotension: a randomized, double-blind, placebo-controlled crossover trial. Clin Auton Res. 2024 Dec;34(6):561-569. doi: 10.1007/s10286-024-01051-2. Epub 2024 Sep 19.
Ikejiri K, Suzuki T, Muto S, Takama H, Yamawaki K, Miyazawa T, Urakawa I, Aoki Y, Otsuki A, Katsuoka F, Kinoshita K, Nangaku M, Akizawa T, Yamamoto M. Effects of NRF2 polymorphisms on safety and efficacy of bardoxolone methyl: subanalysis of TSUBAKI study. Clin Exp Nephrol. 2024 Mar;28(3):225-234. doi: 10.1007/s10157-023-02427-w. Epub 2023 Nov 14.
Other Identifiers
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RTA 402-005
Identifier Type: -
Identifier Source: org_study_id