| Ad Title: |
A study of Chronic Kidney Disease in Type 2 Diabetes |
| Study Title: |
A 52-Week, Multi-center, Double-blind, Randomized, Placebo-controlled Phase IIb Trial to Determine the Effects of Bardoxolone Methyl (RTA402) on eGFR in Patients with Type 2 Diabetes and Chronic Kidney Disease with an eGFR of 20-45 mL/min/1.73m2 |
| Protocol Number: |
032009-023 |
| Department(s) involved in the Study: |
Center for Mineral Metabolism & Clinical Research, Family Practice & Community Medicine, Int Med - Endocrinology
|
| Purpose of the Study: |
Evaluate the effect of bardoxolone methyl, an anti-inflammatory antioxident modulator, in patient with chronic kidney disease and type 2 Diabetes. |
| Participant Eligibility: |
1. Persons with type 2 diabetes at least 18 years old.
2. The Actual estimated GFR value must be within 20-45 mL/min/1.73m2. A formula calculation using the serum creatinine, the patient's age and weight.
3. Patient must be receiving an angiotensin converting enzyme (ACE)inhibitor and/or Angiotensin II receptor blocker (ARB) for at least 3 months prior to screening.
4 The Subject cannot be on immunosuppressive therapy or need steriods within 3 months of study randomization.
5 Must be on stable blood pressure therapy. |
| Disease/Condition Under Study: |
Type 2 diabetes with chronic kidney disease. |
| Cancer Related Study: |
No
|
| Study Drug(s): |
Bardoxolone Methyl
|
| Study Device(s): |
|
| Study Doctor: |
Dr. Philip Raskin |
| Location of Study: |
|
Sites
|
Recruiting at this Site
|
|
Aston Ambulatory Care Center
|
Yes
|
|
UT Southwestern Medical Center, Other: See Comments
|
Yes
|
|
| Contact Phone: |
214_648_4717 |
| Email: |
maria.pruneda@utsouthwestern.edu |
| Other Information: |
If you think you may qualify for this study, please call and we will do lab work at no cost to you to determine your kidney function status and your diabetes glucose control. |
| Website Keywords: |
Diabetes, Endocrinology, Nephrology
|
| Medical Keywords: |
Kidney disease
|
