Clinical Trial Details
| Trial ID: | L1342 |
| Source ID: | NCT01576887 |
| Associated Drug: | Bardoxolone Methyl 20 Mg |
| Title: | A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis |
| Acronym: | |
| Status: | WITHDRAWN |
| Study Results: | NO |
| Results: | |
| Conditions: | End-Stage Renal Disease|Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Bardoxolone Methyl 20 mg|DRUG: Placebo |
| Outcome Measures: | Primary: Number of Adverse Events, Approximately 17 months | Secondary: Type of Adverse Events, Approximately 17 months|Change in Residual Renal Function, Baseline to 6 months|Maximum observed concentration, Day 0, 30, 60, 90, 120, 150, 180, 210|Time to maximum observed concentration, Day 0, 30, 60, 90, 120, 150, 180, 210|Area under the plasma concentration-time curve, Only the first 8 patients randomized will have the PK drawn and hours 2, 4, 8, and 24. All patients will have the PK drawn at 30, 60, 90, 120, 150 and 180 days., 2, 4, 8, 24 hours, 30, 60, 90, 120, 150 and 180 days|Area under the curve, Only the first 8 patients randomized, 2, 4, 8 and 24 hours |
| 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: | 2012-07-31 |
| Completion Date: | 2012-10-31 |
| Results First Posted: | |
| Last Update Posted: | 2024-02-02 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT01576887 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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