| Trial ID: | L1401 |
| Source ID: | NCT01655186
|
| Associated Drug: |
Bardoxolone Methyl
|
| Title: |
A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Effects of Bardoxolone Methyl on Body Composition in Patients With Stage 4 Chronic Kidney Disease and Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Bardoxolone Methyl|DRUG: Placebo
|
| Outcome Measures: |
Primary: Mean change in body weight as measured by Dual Energy X-ray Absorptiometry (DXA), DXA to be done 14 days prior to or after the weeks 12 and 24 visits, Baseline, Weeks 12 and 24 | Secondary: Mean change in fat mass as measured by Dual Energy X-ray Absorptiometry (DXA), DXA to be done 14 days prior to or after the weeks 12 and 24 visits, Baseline, Weeks 12 and 24|Change in visceral fat mass measured by Magnetic Resonance Imaging of the abdomen, MRI to be done 14 days prior to or after the week 24 visit, Baseline and Week 24|Change in hepatic fat mass as measured by Magnetic Resonance Imaging of the liver, MRI to be done 14 days prior to or after the week 24 visit, Baseline and Week 24|Change in left ventricular structure and function as measured by gated Magnetic Resonance Imaging of the heart, MRI to be done 14 days prior to or after the weeks 12 and 24 visits, Baseline, Weeks 12 and 24|Change in gait speed, Baseline, Weeks 12 and 24|Frequency, intensity and relationship of study drug to adverse events and serious adverse events, as well as clinical, and laboratory test result abnormalities, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Reata, a wholly owned subsidiary of Biogen
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09-30
|
| Completion Date: |
2012-10-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-02-02
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01655186
|
