Trials / Terminated
TerminatedNCT01500798
A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes
A Pharmacodynamic Study of Measured Glomerular Filtration Rate Assessed by Tc99m-DTPA in Patients With Chronic Kidney Disease and Type 2 Diabetes
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints.
Detailed description
This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 20 mg bardoxolone methyl | 20 mg, oral, once daily |
| DRUG | Placebo | Oral, once daily |
Timeline
- Start date
- 2012-01-31
- Primary completion
- 2012-11-01
- Completion
- 2013-10-01
- First posted
- 2011-12-28
- Last updated
- 2023-10-27
Source: ClinicalTrials.gov record NCT01500798. Inclusion in this directory is not an endorsement.