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Chronic Kidney DiseasePhase 2NCT00811889

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 (RTA 402) in people with Chronic Kidney Disease and Type 2 Diabetes, run by Biogen at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bardoxolone Methyl (RTA 402)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
42 sitesUnited States
Study dates
30 Apr 2009to 31 Dec 2010
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

  • Male or female patient, at least 18 years of age with known 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)
  • The average of two eGFR values collected during screening must be within 20 - 45 mL/min/1.73m2, inclusive
  • Patient must be receiving an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 3 months prior to screening, where the dose of the ACE inhibitor or the ARB is considered appropriate for that patient, and has been stable and maintained on that dose for at least 8 weeks prior to the Randomization visit
  • For male and female subjects, agreement 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, she must have a negative serum pregnancy test at screening and a negative urine pregnancy test confirmed within 72 hours prior to 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

  • Type 1 (insulin-dependent; juvenile onset) diabetes, or any history of diabetic ketoacidosis
  • Patients with known non-diabetic renal disease or patients with a history of a renal transplant
  • Patients with a Hemoglobin A1c >10% collected at the Screening A visit
  • Cardiovascular disease as follows: Unstable angina pectoris within 3 months prior to study randomization; Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months prior to study randomization; Transient ischemic attack within 3 months of study randomization; Cerebrovascular accident within 3 months of study randomization; Obstructive valvular heart disease or hypertrophic cardiomyopathy; Diagnosis of Class III or IV congestive heart failure at any time
  • Systolic blood pressure (BP) >160 mmHg and diastolic blood pressure > 90 determined by the average of three seated readings taken at least 5 minutes apart, at each of two time-points at least 5 days apart during the screening period
  • QTc Fredericia interval > 450 milliseconds determined by the average of values reported by a central reader from three ECGs taken at the Screening A visit. Each of the three ECGs will be obtained using only equipment provided by the Sponsor, and the ECGs shall be obtained at least ten minutes apart.
Show all 24Show fewer
  • Second or third degree atrioventricular block not successfully treated with a pacemaker
  • Need for chronic (>2 weeks) immunosuppressive therapy, or need for corticosteroids (excluding intraarticular injections,inhaled or nasal steroids) within 3 months of study randomization
  • Evidence of hepatic or biliary dysfunction including total bilirubin >1.0 mg/dL (>17 micromol/L), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > upper limit of normal (ULN), or alkaline phosphatase >2.0 ULN on ANY screening lab
  • If female, patient is pregnant, nursing or planning a pregnancy
  • Patient 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
  • Patient has known hypersensitivity to any component of the study drug
  • Patient has undergone a diagnostic or interventional procedure requiring a contrast agent within 30 days prior to randomization
  • Change or dose adjustment in any of the following medications within 8 weeks prior to randomization into the study or anticipated change in dose within 30 days following randomization into the study: ACE inhibitors, angiotensin II receptor blockers.
  • Change or dose adjustment of any other anti-hypertensive, and other anti-diabetic medications within 8 weeks prior to randomization or anticipated change in dose within 30 days following randomization into the study
  • Patient has a current history of drug or alcohol abuse as per the investigator's assessment
  • Patient has participated in another investigational study within 30 days prior to randomization into the study or would concomitantly participate in such a study, or has previously participated in a trial involving bardoxolone methyl.
  • Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function
  • Patient is unable or unwilling to utilize the daily phone diary to track the date and time they take their study medication
  • Patients on any of the following known hepatotoxic agents: Antioxidant N-acetly-cysteine (Mucomyst, Acetadote, Fluimucil, Parvolex), Niacin (nicotinic acid), Dantrium (dantrolene), Naizide (isoniazid), Normodyne (labetalol), Cylert (pemoline), Felbatol (felbamate), Zyflo (zileuton), Tasmar (tolcapone), or Trovan (trovafloxacin). Patients must have been off the aforementioned medications for a minimum of two weeks prior to randomization
  • Patients who are unable or unwilling to discontinue fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, TriCor, Triglide) during the first three months of study treatment. Patients must have been off fenofibrate for a minimum of two weeks prior to randomization
  • Patients who require more than occasional (once or twice weekly) use of non-steroidal anti-inflammatory agents (NSAIDS)
  • Patients with a history of neoplastic disease (except basal or squamous cell carcinoma of the skin) within 5 years prior to the randomization visit;
  • Patients who have had prior dialysis within three months of randomization and/or have not maintained a stable level of kidney function within three months of randomization per Investigator assessment

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • Study site

    Allentown, Pennsylvania, 18103

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Baton Rouge, Louisiana, 70809

  • Study site

    Birmingham, Alabama, 35294

  • Study site

    Brandon, Florida, 33511

  • Study site

    Brooklyn Center, Minnesota, 55430

  • Study site

    Chicago, Illinois, 60616

  • Study site

    Chula Vista, California, 91910

  • Study site

    Corpus Christi, Texas, 78404

  • Study site

    Dallas, Texas, 75390

  • Study site

    El Paso, Texas, 79935

  • Study site

    Federal Way, Washington, 98003

  • Study site

    Flint, Michigan, 48504

  • Study site

    Flushing, New York, 11355

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    La Mesa, California, 91942

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33173

  • Study site

    Middlebury, Connecticut, 06762

  • Study site

    Mission Viejo, California, 92691

  • Study site

    Montgomery, Alabama, 36106

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    Orange, California, 92868

  • Study site

    Pembroke Pines, Florida, 33028

  • Study site

    Peoria, Illinois, 61603

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Pittsburgh, Pennsylvania, 15240

  • Study site

    Port Charlotte, Florida, 33952

  • Study site

    Portland, Maine, 04102

  • Study site

    Providence, Rhode Island, 02904

  • Study site

    Riverside, California, 92505

  • Study site

    Roseburg, Oregon, 97471

  • Study site

    Salem, Virginia, 24153

  • Study site

    San Antonio, Texas, 78205

  • Study site

    San Antonio, Texas, 78215

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Dimas, California, 91773

  • Study site

    Springfield Gardens, New York, 11413

  • Study site

    Washington D.C., District of Columbia, 20036

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A 52-Week, Multi-center, Double-blind, Randomized, Placebo-controlled Phase IIb Trial to Determine the Effects of Bardoxolone Methyl (RTA 402) on eGFR in Patients With Type 2 Diabetes and Chronic Kidney Disease With an eGFR of 20 - 45 mL/Min/1.73m2

This study assesses the effects of bardoxolone methyl (RTA 402) in patients with type 2 diabetes and chronic kidney disease.

Read the detailed description

Bardoxolone methyl (RTA 402) is an Antioxidant Inflammation Modulator (AIM) that is undergoing clinical testing in chronic kidney disease (CKD) and cancer. Bardoxolone methyl and other AIMs inhibit immune-mediated inflammation by restoring redox homeostasis in inflamed tissues by inducing 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. This process causes further activation of NF-kB, creating a vicious cycle of inflammation, vasoconstriction, and ischemia, the end result of which is sclerosis in the kidney and coronary arteries. By inducing Nrf2 and suppressing redox-driven inflammation, we hypothesize that this cycle of inflammation and sclerosis can be abrogated.

Based on Phase IIa data, we hypothesize that bardoxolone methyl will improve renal function through suppression of renal oxidative stress, inflammation and improvement of glomerular filtration. This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.

Being tested
Placebo, Bardoxolone Methyl (RTA 402)
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.

  • PlaceboOther

    Placebo

  • Bardoxolone Methyl (RTA 402)Drug

    Oral, Once Daily

Study groups in NCT00811889
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
Bardoxolone Methyl (RTA 402): 75mgExperimentalNot described
Receives: Drug: Bardoxolone Methyl (RTA 402)
Bardoxolone Methyl (RTA 402): 150mgExperimentalNot described
Receives: Drug: Bardoxolone Methyl (RTA 402)
Bardoxolone Methyl (RTA 402): 25mgExperimentalNot described
Receives: Drug: Bardoxolone Methyl (RTA 402)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization

    Measured: 6 months (24 weeks)

  2. To determine the safety and tolerability of bardoxolone methyl when administered for 12 months (52 weeks)following randomization to type 2 diabetic patients with CKD (eGFR 20 - 45 mL/min/1.73m2).

    Measured: 1 year (52 weeks)

Secondary outcomes (2)

  1. To quantify the effects of bardoxolone methyl at two different dosing levels relative to placebo on: Hemoglobin A1c, Serum Creatinine, Urine, Intact PTH albumin/creatinine ratio, Serum Phosphorus, Blood Urea Nitrogen, Uric Acid

    Measured: 6 months (24 weeks) and 1 year (52 weeks)

  2. To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 12 months (52 weeks) following randomization.

    Measured: 12 months (52 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2008 (estimated)
  2. Study start30 Apr 2009
  3. Primary completion31 May 2010
  4. Study completion31 Dec 2010

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00811889
Sponsor's protocol ID
RTA 402-C-0804
Status last verified
May 2025
First submitted
18 Dec 2008
Last updated
29 May 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Publications

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PubMed 37916745

  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

    PubMed 33782940

  • Pergola PE, Raskin P, Toto RD, Meyer CJ, Huff JW, Grossman EB, Krauth M, Ruiz S, Audhya P, Christ-Schmidt H, Wittes J, Warnock DG; BEAM Study Investigators. Bardoxolone methyl and kidney function in CKD with type 2 diabetes. N Engl J Med. 2011 Jul 28;365(4):327-36. doi: 10.1056/NEJMoa1105351. Epub 2011 Jun 24.

    PubMed 21699484

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bardoxolone Methyl (RTA 402) in people with Chronic Kidney Disease and Type 2 Diabetes, run by Biogen at 42 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 7 inclusion and 24 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 42 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. Some participants in this study may receive a placebo. 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 determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization (time frame: 6 months (24 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00811889, which also lists 3 linked publications.

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.

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