Clinical Trial Details
| Trial ID: | L1022 |
| Source ID: | NCT01500798 |
| Associated Drug: | 20 Mg Bardoxolone Methyl |
| Title: | A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Type 2 Diabetes |
| Interventions: | DRUG: 20 mg bardoxolone methyl|DRUG: Placebo |
| Outcome Measures: | Primary: Measured GFR assessed by plasma clearance of Tc99m-DTPA, Measured GFR assessed by plasma clearance of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20, 24 weeks | Secondary: Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA, Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20, 24 weeks|Circulating endothelial cell assessments, Circulating endothelial cell assessments at Baseline mGFR assessment 1 and at Weeks 8 and 20, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Biogen |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE1 |
| Enrollment: | 18 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-01-31 |
| Completion Date: | 2013-10-01 |
| Results First Posted: | |
| Last Update Posted: | 2023-10-27 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT01500798 |
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