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Clinical Trial Details

Trial ID: L0878
Source ID: NCT02316821
Associated Drug: Rta 402
Title: The Phase II Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Type 2 Diabetes
Interventions: DRUG: RTA 402|DRUG: Placebo
Outcome Measures: Primary: Safety: Number and types of adverse events, Count of adverse events, by type, in the bardoxolone methyl arm compared to the placebo arm, Up to 16 weeks|Change in glomerular filtration rate (GFR) measured by inulin clearance after 16 weeks of study drug administration, compared to baseline GFR, Change in GFR from baseline to 16 weeks, Up to 16 weeks | Secondary: Change in estimated GFR (eGFR) after 16 weeks of study drug administration, compared to baseline eGFR, Change in eGFR from baseline to 16 weeks, Up to 16 weeks|Profiles of pharmacokinetics of plasma RTA 402 concentration: Trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state, Relationship between the study drug dose and the trough (Pre-dose) and peak (2-4 hours post dose) concentrations of study drug at steady state, Baseline, week 2, 6, 10, and 4 weeks after completion of study treatment
Sponsor/Collaborators: Sponsor: Kyowa Kirin Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 216
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-12
Completion Date: 2017-09
Results First Posted:
Last Update Posted: 2017-10-27
Locations: Tokyo, Japan
URL: https://clinicaltrials.gov/show/NCT02316821