Renal Insufficiency, ChronicPhase 3BEACONNCT01351675
Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes
A Phase 3 study testing Bardoxolone Methyl: 20 mg in people with Renal Insufficiency, Chronic and Diabetes Mellitus, Type 2, run by Biogen.
Trial summary
This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care. 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: 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,185 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2011to 31 Dec 2012
- Phase
- Phase 3
- 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
- Screening eGFR ≥ 15.0 and < 30.0 mL/min/1.73 m2;
- A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age;
- Male or female at least 18 years of age;
- Treatment with an angiotensin converting enzyme (ACE)inhibitor and/or an angiotensin II receptor blocker (ARB)for at least 6 weeks prior to and during screening. Stable dose 2 weeks prior to and during screening. Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to Screening Visit A;
- Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mm Hg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within this range at two separate time points measured at least 4 days apart during the screening period (blood pressure may be re-evaluated once during an unscheduled visit);
- Willing to practice methods of birth control (both male and female patients) during the entire study period and for at least 30 days after the last dose of the study drug is ingested;
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- Serum magnesium level must be ≥ 1.3 mEq/L (0.65 mmol/L) at Screening Visit B or during subsequent unscheduled visit during screening (serum magnesium level may be re-evaluated once during an unscheduled visit);
- Willing and able to cooperate with all aspects of the protocol;
- Willing and able to give written informed consent for study participation and provide consent for access to medical data according to appropriate local data protection legislation, allowing authorization to access medical records and describe events captured in the endpoints
Who cannot join
- Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes;
- Known non-diabetic renal disease (e.g., polycystic kidney disease, focal segmental glomerulosclerosis) [nephrosclerosis superimposed on diabetic kidney disease is acceptable];
- Ongoing clinical evidence suggesting non-diabetic renal disease other than nephrosclerosis;
- History of a renal transplant or a planned transplant from a living donor during the study;
- Albumin to creatinine ratio (ACR) greater than 3500 mg/g (395.5 mg/mmol);
- Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening;
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- Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening;
- Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following randomization, as assessed by the investigator;
- Recently active cardiovascular disease defined as: a. Unstable angina pectoris within 12 weeks before study randomization; b. Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before study randomization; c. Cerebrovascular accident, including transient ischemic attack within 12 weeks before study randomization; d. Current diagnosis of Class III or IV New York Heart Association (NYHA) congestive heart failure;
- Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy;
- Atrioventricular block, 2o or 3o, not successfully treated with a pacemaker;
- DAdministration of a contrast agent that may induce nephropathy within 30 days prior to study randomization or planned during the study;
- Systemic immunosuppression for a total of > 2 weeks, cumulatively, within the 12 weeks prior to randomization or planned during the study;
- Total bilirubin, aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) levels greater than the upper limit of normal (ULN), or alkaline phosphatase level greater than two times the ULN on ANY screening laboratory test result;
- Female patients who are pregnant, intend to become pregnant during the study, or are nursing;
- BMI < 18.5 g/m2
- Known hypersensitivity to any component of the study drug;
- Current history of drug or alcohol abuse as assessed by the investigator;
- Clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 6 weeks of screening or during screening;
- Hepatitis B surface antigen positive;
- Diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix or a condition highly likely to transform into malignancy during the course of the study;
- A clinical condition that in the judgment of the investigator could potentially pose a health risk to the patient while involved in the study;
- Participation in a clinical study involving any intervention within 30 days prior to randomization, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form;
- Unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function.
About this study
Official title: Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON)
This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.
- Being tested
- Placebo, Bardoxolone Methyl: 20 mg
- 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.
PlaceboDrug
Oral, once daily
Bardoxolone Methyl: 20 mgDrug
Also called RTA-402
20 mg, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Bardoxolone Methyl | Experimental | Not described Receives: Drug: Bardoxolone Methyl: 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-first event of the composite endpoint
Time-to-first event of the composite endpoint consisting of:
- ESRD (need for chronic dialysis or renal transplantation)
- Cardiovascular death
Measured: Approximately 24 months
Secondary outcomes (4)
Rate of change in estimated glomerular filtration rate (eGFR) over the duration of the study
Measured: Approximately 24 months
Time to first hospitalization for heart failure
Measured: Approximately 24 months
Time to first event in the composite cardiorenal endpoint
Time-to-first event in the composite cardiorenal endpoint defined as:
- Cardiovascular death
- Non-fatal myocardial infarction
- Non-fatal stroke
- Hospitalization for heart failure
Measured: Approximately 24 months
Frequency, intensity, and relationship to study drug of adverse events and serious adverse events, as well as clinical and laboratory test abnormalities.
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study start30 Jun 2011
- Primary completion31 Oct 2012
- Study completion31 Dec 2012
Why it stopped: IDMC recommendation for safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351675
- Sponsor's protocol ID
- 402-C-0903
- Acronym
- BEACON
- Status last verified
- May 2025
- First submitted
- 3 Dec 2010
- 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 37916745Conley 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 33782940de Zeeuw D, Akizawa T, Audhya P, Bakris GL, Chin M, Christ-Schmidt H, Goldsberry A, Houser M, Krauth M, Lambers Heerspink HJ, McMurray JJ, Meyer CJ, Parving HH, Remuzzi G, Toto RD, Vaziri ND, Wanner C, Wittes J, Wrolstad D, Chertow GM; BEACON Trial Investigators. Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease. N Engl J Med. 2013 Dec 26;369(26):2492-503. doi: 10.1056/NEJMoa1306033. Epub 2013 Nov 9.
PubMed 24206459
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
- Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON)
- ClinicalTrials.gov ID
- NCT01351675
- Acronym / sponsor ID
- BEACON / 402-C-0903
- Keywords
- Chronic kidney disease, Type 2 diabetes, Diabetic nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDMC recommendation for safety concerns
- Enrolment
- 2,185 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2011 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Dec 2012 (actual)
- First posted
- 11 May 2011 (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 efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Bardoxolone Methyl | Experimental | Drug: Bardoxolone Methyl: 20 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Screening eGFR ≥ 15.0 and < 30.0 mL/min/1.73 m2;
- A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age;
- Male or female at least 18 years of age;
- Treatment with an angiotensin converting enzyme (ACE)inhibitor and/or an angiotensin II receptor blocker (ARB)for at least 6 weeks prior to and during screening. Stable dose 2 weeks prior to and during screening. Patients not taking an ACE inhibitor and/or ARB because of a medical contraindication must have discontinued treatment at least 8 weeks prior to Screening Visit A;
- Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mm Hg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within this range at two separate time points measured at least 4 days apart during the screening period (blood pressure may be re-evaluated once during an unscheduled visit);
Key exclusion criteria (24 listed)
- Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes;
- Known non-diabetic renal disease (e.g., polycystic kidney disease, focal segmental glomerulosclerosis) [nephrosclerosis superimposed on diabetic kidney disease is acceptable];
- Ongoing clinical evidence suggesting non-diabetic renal disease other than nephrosclerosis;
- History of a renal transplant or a planned transplant from a living donor during the study;
- Albumin to creatinine ratio (ACR) greater than 3500 mg/g (395.5 mg/mmol);
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 |
|---|---|---|
| PlaceboOral, once daily | Drug | Placebo |
| Bardoxolone Methyl: 20 mgAlso: RTA-40220 mg, oral, once daily | Drug | Bardoxolone Methyl |
Primary outcome
Time-to-first event of the composite endpoint
Time frame: Approximately 24 months
Time-to-first event of the composite endpoint consisting of: * ESRD (need for chronic dialysis or renal transplantation) * Cardiovascular death
4 secondary outcomes
Rate of change in estimated glomerular filtration rate (eGFR) over the duration of the study
Time frame: Approximately 24 months
Time to first hospitalization for heart failure
Time frame: Approximately 24 months
Time to first event in the composite cardiorenal endpoint
Time frame: Approximately 24 months
Frequency, intensity, and relationship to study drug of adverse events and serious adverse events, as well as clinical and laboratory test abnormalities.
Time frame: Approximately 24 months
Results and safety
The study was stopped early (reason given: IDMC recommendation for safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Derived from this study: PubMed 37916745Colombijn 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.
- Derived from this study: PubMed 33782940Conley 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.
- Derived from this study: PubMed 24206459de Zeeuw D, Akizawa T, Audhya P, Bakris GL, Chin M, Christ-Schmidt H, Goldsberry A, Houser M, Krauth M, Lambers Heerspink HJ, McMurray JJ, Meyer CJ, Parving HH, Remuzzi G, Toto RD, Vaziri ND, Wanner C, Wittes J, Wrolstad D, Chertow GM; BEACON Trial Investigators. Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease. N Engl J Med. 2013 Dec 26;369(26):2492-503. doi: 10.1056/NEJMoa1306033. Epub 2013 Nov 9.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bardoxolone Methyl: 20 mg in people with Renal Insufficiency, Chronic and Diabetes Mellitus, Type 2, run by Biogen.
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 9 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: stopped early, 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.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: IDMC recommendation for safety concerns). Results are not available in the source record.
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?
Time-to-first event of the composite endpoint (time frame: Approximately 24 months). 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 NCT01351675, 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.