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Clinical Trial Details

Trial ID: L1295
Source ID: NCT01551446
Associated Drug: Bardoxolone Methyl
Title: Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in Patients With Chronic Kidney Disease and Type 2 Diabetes
Acronym:
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Renal Insufficiency, Chronic|Diabetes Mellitus, Type 2
Interventions: DRUG: Bardoxolone Methyl
Outcome Measures: Primary: Change in renal perfusion, The change in renal perfusion measured by ASL-MRI Scanning, 20 weeks | Secondary: Change in cardiac function, The change in cardiac function measured by cardiac MRI scanning, 20 weeks|Change in cerebral perfusion, The change in cerebral perfusion measured by cerebral ASL MRI, 20 weeks|Change in haemodynamic variables, The change in the following haemodynamic variables: non-invasive measurement of cardiac output, heart rate, blood pressure and baroreflex sensitivity, 20 weeks|Change in arterial stiffness, The change in arterial stiffness measured using cartoi-femoral Pulsewave Velocity Assessment and Augmentation Index, 20 weeks|Change in body composition, The change in body composition measured using Bioelectrical Impedance Analysis, 20 weeks|Number of participants with adverse events and serious adverse events, 20 weeks|Plasma concentration of bardoxolone methyl, 20 weeks|Change in cerebral white matter microstructure, 20 weeks|Change in total body water, The change in total body water measured using Bioelectrical Impedance Analysis, 20 weeks
Sponsor/Collaborators: Sponsor: Reata, a wholly owned subsidiary of Biogen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-04-30
Completion Date: 2012-11-30
Results First Posted:
Last Update Posted: 2024-02-02
Locations:
URL: https://clinicaltrials.gov/show/NCT01551446