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Sponsored by: |
Reata Pharmaceuticals, Inc. |
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Information provided by: | Reata Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00664027 |
To determine the effects of three different doses of bardoxolone administered orally on the kidney function (glomular filtration rate) in patients with diabetic nephropathy.
Condition | Intervention | Phase |
---|---|---|
Diabetic Nephropathy |
Drug: RTA 402 (Bardoxolone Methyl) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 80 |
Study Start Date: | April 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
25mg
|
Drug: RTA 402 (Bardoxolone Methyl) |
2: Experimental
75mg
|
Drug: RTA 402 (Bardoxolone Methyl) |
3: Experimental
150mg
|
Drug: RTA 402 (Bardoxolone Methyl) |
4: Experimental
25 mg -> 75 mg
|
Drug: RTA 402 (Bardoxolone Methyl) |
Bardoxolone is an Antioxidant Inflammation Modulator (AIM) 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
DGD Research | |
San Antonio, Texas, United States, 78229 | |
Renal Associates, PA | |
San Antonio, Texas, United States, 78215 | |
West Houston Clinical Research Services | |
Houston, Texas, United States, 77055 |
Study ID Numbers: | RTA 402-C-0801 |
Study First Received: | April 18, 2008 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00664027 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Kidney Diseases Diabetes Complications |
Diabetic Nephropathies Urologic Diseases Diabetes Mellitus |
Endocrine System Diseases Kidney Diseases Diabetes Complications |