Renal Insufficiency, ChronicPhase 2NCT01053936
Phase II Pharmacodynamic Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease
A Phase 2 study testing Bardoxolone methyl (amorphous dispersion) in people with Renal Insufficiency, Chronic and Diabetes Mellitus, Type 2, run by Biogen at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
- What is being tested?
- Bardoxolone methyl (amorphous dispersion)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 26 sitesUnited States
- Study dates
- 31 Jan 2010to 28 Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 29Show fewer
- 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;
- 2nd 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;
- Any patient who requires more than occasional (once or twice weekly) use of non-steroidal anti-inflammatory agents (NSAIDS);
- Any patient who requires a change or dose adjustment in any of the following medications: ACE inhibitors and ARBs within 8 weeks; other anti-hypertensive, and other anti-diabetic medications within 6 weeks prior to study randomization;
- Any patient who is unable or unwilling to discontinue the following medications throughout the study period: Niacin® (nicotinic acid), Niaspan® (nicotinic acid), Niacor® (nicotinic acid), Nicolar® (nicotinic acid),Nicobid® (nicotinic acid), Nydrazid® (isoniazid), Dantrium® (dantrolene), Normodyne® (labetalol), Trandate® (labetalol), Cylert® (pemoline), Tradon® (pemoline), PemADD® (pemoline), Felbatol® (felbamate), Zyflo® (zileuton),Tasmar® (tolcapone), or Tricor® (fenofibrate), Antaram® (fenofibrate), Triglide® (fenofibrate), Lofibra® (fenofibrate), Lipidil Micro® (fenofibrate), Lipidil Supra® (fenofibrate); including fenofibrate derivatives e.g. Lopid® (gemfibrozil) and Atromid-S® (clofibrate) . Patient must discontinue the aforementioned medications for a minimum of two weeks prior to randomization. Patients may continue use of multi-vitamins (e.g., Centrum) ®, which have a maximum total daily consumption of <= 50 mg of nicotinic acid (Niacin®);
- Any patient with evidence of hepatic or biliary dysfunction including levels of total bilirubin >1.0 mg/dL (>17 micromole/L), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > upper limit of normal (ULN), or alkaline phosphatase >2.0 times the ULN on ANY screening laboratory test result;
- If a patient provides a history of hepatitis B or C but has normal liver enzyme levels, the investigator should perform a serologic hepatitis screen and call the Medical Monitor to discuss patient eligibility. Patients with a history of hepatitis A that is resolved and who do not demonstrate any liver enzyme level elevation are eligible for protocol randomization;
- Any female patient who is pregnant, nursing or planning a pregnancy;
- Any patient with known hypersensitivity to any component of the study drug;
- Any patient who has undergone diagnostic or intervention procedure requiring a contrast agent within the last 30 days prior to study randomization;
- Patient with a current history of drug or alcohol abuse as per the Investigator's assessment;
- Any patient with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to study randomization;
- Any patient who has had dialysis within 3 months before randomization and/or have not maintained a stable level of kidney function within 3 months of randomization per Investigator assessment;
- Any patient who has any concurrent clinical conditions that in the judgment of the investigator could either potentially pose a health risk to the patient while involved in the study or could potentially influence the study outcome;
- Any patient who has participated in another clinical study involving investigational or marketed products within 30 days prior to randomization or would concomitantly participate in such a study, or any patient who has received bardoxolone methyl in any form;
- Any patient who is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Augusta, Georgia, 30901
Study site
Brandon, Florida, 33511
Study site
Brooklyn Center, Minnesota, 55430
Study site
Canton, Georgia, 30114
Study site
Chattanooga, Tennessee, 37304
Study site
Chicago, Illinois, 60616
Study site
Corpus Christi, Texas, 78404
Study site
Dallas, Texas, 75390
Study site
Federal Way, Washington, 98003
Study site
Greenville, Texas, 75402
Study site
Houston, Texas, 77099
Study site
La Mesa, California, 91942
Study site
Montgomery, Alabama, 36106
Study site
Morehead City, North Carolina, 28557
Study site
Peoria, Illinois, 61603
Study site
Phoenix, Arizona, 85012
Study site
Pittsburgh, Pennsylvania, 15224
Study site
Port Charlotte, Florida, 33952
Study site
Providence, Rhode Island, 02904
Study site
Riverside, California, 92505
Study site
San Antonio, Texas, 78215
Study site
San Dimas, California, 91773
Study site
Tempe, Arizona, 85284
Study site
Washington D.C., District of Columbia, 20036
Study site
West Palm Beach, Florida, 33401
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: 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)
This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
Read the detailed description
Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD). Bardoxolone methyl and other AIMs inhibit immune-mediated inflammation by restoring redox homeostasis in inflamed tissues through the induction of the cytoprotective transcription factor Nrf2. In the diabetic population, adipocytes produce cytokines and mobilize free fatty acids which induce insulin resistance. Resultant hyperglycemia and increased cytokine production induces reactive oxygen and nitrogen species which in turn induce vascular inflammation and endothelial dysfunction. These stimuli cause further activation of NF-kB, promoting inflammation, mesangial cell contraction, mesangial expansion and endothelial dysfunction, the end result of which is decreased renal function. By inducing Nrf2 and suppressing redox-driven inflammation, we hypothesize that inflammation and resultant adverse renal functional changes in patients with chronic kidney disease resulting from diabetes can be suppressed.
In a Phase IIa open label study of patients with CKD and type 2 diabetes, treatment with bardoxolone methyl for 28 days resulted in significant improvements in renal function, including increases in eGFR, and decreases in serum creatinine, cystatin C, BUN, phosphorus, uric acid, creatinine clearance, and angiotensin II; improvements in glycemic control as assessed by hemoglobin A1c; and improvements in markers of endothelial dysfunction and systemic inflammation, such as circulating endothelial cells and adiponectin. These data are consistent with the hypothesis that bardoxolone methyl improves renal function through suppression of renovascular oxidative stress and inflammation.
A new formulation of bardoxolone methyl has been developed, which is the same chemical entity but manufactured to contain an amorphous dispersion rather than a crystalline solid state. The new amorphous dispersion formulation of bardoxolone methyl has been shown to be more orally bioavailable in non-human primates. The purpose of this study is to determine the appropriate dose of the new bardoxolone methyl formulation to use in future clinical studies by determining the dose response relationship on eGFR.
- Being tested
- Bardoxolone methyl (amorphous dispersion)
- Keywords
- Chronic Kidney Disease, Type 2 diabetes, Diabetic Nephropathy
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone methyl (amorphous dispersion)Drug
Oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Bardoxolone methyl: 5 mg | Experimental | Not described Receives: Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 10 mg | Experimental | Not described Receives: Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 15 mg | Experimental | Not described Receives: Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 30 mg | Experimental | Not described Receives: Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 2.5 mg | Experimental | Not described Receives: Drug: Bardoxolone methyl (amorphous dispersion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 29 Days
Secondary outcomes (2)
To evaluate the safety and tolerability of bardoxolone methyl (amorphous dispersion) after 28 and 84 days of administration.
Measured: 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)
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study start31 Jan 2010
- Primary completion31 Dec 2010
- Study completion28 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053936
- Sponsor's protocol ID
- RTA 402-C-0902
- Status last verified
- May 2025
- First submitted
- 20 Jan 2010
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT01053936
- Acronym / sponsor ID
- RTA 402-C-0902
- Keywords
- Chronic Kidney Disease, Type 2 diabetes, Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2010 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 28 Feb 2011 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assesses the effects of a new formulation of bardoxolone methyl on eGFR in Patients with Chronic Kidney Disease and Type 2 Diabetes.
Detailed description
Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD). Bardoxolone methyl and other AIMs inhibit immune-mediated inflammation by restoring redox homeostasis in inflamed tissues through the induction of the cytoprotective transcription factor Nrf2. In the diabetic population, adipocytes produce cytokines and mobilize free fatty acids which induce insulin resistance. Resultant hyperglycemia and increased cytokine production induces reactive oxygen and nitrogen species which in turn induce vascular inflammation and endothelial dysfunction. These stimuli cause further activation of NF-kB, promoting inflammation, mesangial cell contraction, mesangial expansion and endothelial dysfunction, the end result of which is decreased renal function. By inducing Nrf2 and suppressing redox-driven inflammation, we hypothesize that inflammation and resultant adverse renal functional changes in patients with chronic kidney disease resulting from diabetes can be suppressed.
In a Phase IIa open label study of patients with CKD and type 2 diabetes, treatment with bardoxolone methyl for 28 days resulted in significant improvements in renal function, including increases in eGFR, and decreases in serum creatinine, cystatin C, BUN, phosphorus, uric acid, creatinine clearance, and angiotensin II; improvements in glycemic control as assessed by hemoglobin A1c; and improvements in markers of endothelial dysfunction and systemic inflammation, such as circulating endothelial cells and adiponectin. These data are consistent with the hypothesis that bardoxolone methyl improves renal function through suppression of renovascular oxidative stress and inflammation.
A new formulation of bardoxolone methyl has been developed, which is the same chemical entity but manufactured to contain an amorphous dispersion rather than a crystalline solid state. The new amorphous dispersion formulation of bardoxolone methyl has been shown to be more orally bioavailable in non-human primates. The purpose of this study is to determine the appropriate dose of the new bardoxolone methyl formulation to use in future clinical studies by determining the dose response relationship on eGFR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bardoxolone methyl: 5 mg | Experimental | Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 10 mg | Experimental | Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 15 mg | Experimental | Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 30 mg | Experimental | Drug: Bardoxolone methyl (amorphous dispersion) |
| Bardoxolone methyl: 2.5 mg | Experimental | Drug: Bardoxolone methyl (amorphous dispersion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (29 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bardoxolone methyl (amorphous dispersion)Oral, once daily | Drug | Bardoxolone methyl: 10 mg, Bardoxolone methyl: 15 mg, Bardoxolone methyl: 2.5 mg, Bardoxolone methyl: 30 mg, Bardoxolone methyl: 5 mg |
Primary outcome
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).
Time frame: 29 Days
2 secondary outcomes
To evaluate the safety and tolerability of bardoxolone methyl (amorphous dispersion) after 28 and 84 days of administration.
Time frame: 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)
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bardoxolone methyl (amorphous dispersion) in people with Renal Insufficiency, Chronic and Diabetes Mellitus, Type 2, run by Biogen at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 29 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.