Trials / Completed
CompletedNCT00664027
Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic Nephropathy
An Open-Label, Randomized, Dose-ranging Phase IIa Trial to Determine the Effects of RTA 402 (Bardoxolone Methyl) on Renal Function in Patients With Diabetic Nephropathy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the effects of three different doses of bardoxolone methyl administered orally on the kidney function (glomular filtration rate) in patients with diabetic nephropathy.
Detailed description
Bardoxolone methyl is an Antioxidant Inflammation Modulator in clinical development for inflammation and cancer-related indications that inhibits immune-mediated inflammation by restoring redox homeostasis in inflamed tissues. It induces the cytoprotective transcription factor Nrf2 and suppresses the activities of the pro-oxidant and pro-inflammatory transcription factors NF-kB and the STATs. In vivo, bardoxolone has demonstrated significant single agent anti-inflammatory activity in several animal models of inflammation such as renal damage in the cisplatin model and ischemia-reperfusion model of acute renal injury. In addition, significant reductions in serum creatinine have been observed in patients treated with bardoxolone. Based on these data, it is hypothesized that bardoxolone can improve renal function in patients with diabetic nephropathy through suppression of renal inflammation and improvement of glomerular filtration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RTA 402 (Bardoxolone Methyl) | Stratum 1: 25, 75, 150mg/day, orally, 28 consecutive days Stratum 2: 25 mg/day, orally, 28 consecutive days followed by 75 mg/day, orally, 28 consecutive days |
Timeline
- Start date
- 2008-04-30
- Primary completion
- 2009-05-31
- Completion
- 2009-05-31
- First posted
- 2008-04-22
- Last updated
- 2025-05-29
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00664027. Inclusion in this directory is not an endorsement.