Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease
A Multi-Center, Open-Label, Randomized, Parallel Group, Dose-Ranging, Pharmacodynamic Phase II Trial to Determine the Effects of Bardoxolone Methyl (RTA 402, Amorphous Dispersion) on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease (eGFR 15-45 mL/Min/1.73m2)
1 other identifier
interventional
129
1 country
26
Brief Summary
This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2010
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedStudy Start
First participant enrolled
January 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2011
CompletedMay 29, 2025
May 1, 2025
11 months
January 20, 2010
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess a trend in mean change from baseline to Day 29 in eGFR (as estimated by the 4-component MDRD formula) with increasing doses of bardoxolone methyl (amorphous dispersion) in patients with Type 2 diabetes and CKD (eGFR 15-45 mL/min/1.73m2).
29 Days
Secondary Outcomes (2)
To evaluate the safety and tolerability of bardoxolone methyl (amorphous dispersion) after 28 and 84 days of administration.
85 days
To assess a trend in mean change from baseline to Day 85 in eGFR (as estimated by the 4-component MDRD formula with increasing doses of bardoxolone methyl (amorphous dispersion) in patients with Type 2 diabetes and CKD (eGFR 15-45 mL/min/1.73m2)
85 days
Study Arms (5)
Bardoxolone methyl: 5 mg
EXPERIMENTALBardoxolone methyl: 10 mg
EXPERIMENTALBardoxolone methyl: 15 mg
EXPERIMENTALBardoxolone methyl: 30 mg
EXPERIMENTALBardoxolone methyl: 2.5 mg
EXPERIMENTALInterventions
Oral, once daily
Eligibility Criteria
You may qualify if:
- Patients must have a history of type 2 diabetes; diagnosis of type 2 diabetes should have been made at \>30 years of age (if diabetes developed at a younger age, C-peptide level may be obtained to confirm diagnosis);
- Patients must be at least 18 years of age;
- The average of 2 eGFR values collected during screening must be within 15 - 45 mL /min/1.73m2 inclusive.
- Patients must be receiving an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 8 weeks prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and the patient has been stable and maintained on that dose for at least 8 weeks prior to randomization (Day 1). No change in ACE or ARB therapy should be anticipated or planned for the period of the study.
- Male and female patients must agree to use effective contraception during the entire study period and for at least 2 months after the last dose of study drug, unless documentation of infertility exists
- Women of child-bearing potential must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to administration of the first dose of study medication;
- Patient is willing and able to cooperate with all aspects of the protocol;
- Patient is willing and able to give written informed consent for study participation
You may not qualify if:
- Any patient with Type 1 (insulin-dependent; juvenile onset) diabetes; or any history of diabetic ketoacidosis;
- Any patient with known non-diabetic renal disease, family history of a hereditary form of kidney disease, or patients with a history of a renal transplant.
- Any patient with clinical or renal biopsy evidence of any non-diabetic renal disease other than nephro-sclerosis;
- Any patient with blood pressure (BP) that is unable to be controlled to a systolic pressure (SeSBP) \<160 mmHg and a diastolic pressure (SeDBP) of \<90 mmHg. BP will be determined by the average of 3 readings, taken after being seated for at least 5-minutes. BP must be within this range taken at 2 separate time-points at least 4 days apart during the screening period;
- Any patient with Hemoglobin A1c level \>10% collected at screening;
- Any patient with cardiovascular disease as follows:
- Unstable angina pectoris within 3 months before study randomization;
- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months before study randomization;
- Transient ischemic attack within 3 months before study randomization;
- Cerebrovascular accident within 3 months before study randomization;
- Obstructive valvular heart disease or hypertrophic cardiomyopathy;
- nd degree or 3rd degree atrioventricular block not successfully treated with a pacemaker;
- Current diagnosis of Class III or IV congestive heart failure ;
- Any patient with QTc Fredericia interval \> 450 milliseconds as determined by the average of values reported by a central reader from 3 ECGs taken at the Screening Visit.
- Any patient with need for chronic (\>2 weeks) immunosuppressive therapy, including corticosteroids (excluding intra-articular injections inhaled or nasal steroids) within 3 months prior to randomization;
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (26)
Unknown Facility
Montgomery, Alabama, 36106, United States
Unknown Facility
Phoenix, Arizona, 85012, United States
Unknown Facility
Tempe, Arizona, 85284, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Riverside, California, 92505, United States
Unknown Facility
San Dimas, California, 91773, United States
Unknown Facility
Washington D.C., District of Columbia, 20036, United States
Unknown Facility
Brandon, Florida, 33511, United States
Unknown Facility
Port Charlotte, Florida, 33952, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Unknown Facility
Canton, Georgia, 30114, United States
Unknown Facility
Chicago, Illinois, 60616, United States
Unknown Facility
Peoria, Illinois, 61603, United States
Unknown Facility
Brooklyn Center, Minnesota, 55430, United States
Unknown Facility
Morehead City, North Carolina, 28557, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15224, United States
Unknown Facility
Providence, Rhode Island, 02904, United States
Unknown Facility
Chattanooga, Tennessee, 37304, United States
Unknown Facility
Corpus Christi, Texas, 78404, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Greenville, Texas, 75402, United States
Unknown Facility
Houston, Texas, 77099, United States
Unknown Facility
San Antonio, Texas, 78215, United States
Unknown Facility
Federal Way, Washington, 98003, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
January 31, 2010
Primary Completion
December 31, 2010
Study Completion
February 28, 2011
Last Updated
May 29, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/