End-Stage Renal DiseasePhase 2NCT01576887
A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis
A Phase 2 study testing Bardoxolone Methyl 20 mg in people with End-Stage Renal Disease and Type 2 Diabetes Mellitus, run by Biogen.
Trial summary
This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease, Type 2 Diabetes Mellitus
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2012to 31 Oct 2012
- 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 ESRD and been on PD for longer than 3 months
- Patients must have had a diagnosis of T2DM prior to starting dialysis
- Patients must have RRF, as defined by the mean of urea and creatinine clearance on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 documented in the four months prior to the Screen A visit
- Patients must have RRF, as defined by the mean of urea and creatinine clearances on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 at both the Screen A and Screen B visits
- The RRF value obtained at the Screen B visit, must not be less than 50% of the RRF value obtained at the Screen A visit
- Patients must be at least 18 years of age
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- Patients must have a mean systolic blood pressure (SBP) on three readings at both Screen A and Screen B visits ≤ 160 mmHg and ≥ 90 mmHg
- Patients must have a mean diastolic blood pressure (DBP) on three readings at both Screen A and Screen B visits < 100 mmHg and ≥ 40 mmHg
- Patients must be willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested
- Patients must be willing and able to cooperate with all aspects of the protocol
- Patients must be willing and able to give written informed consent to participate in the study. They must provide consent for access to medical data according to appropriate local data protection legislation and allow authorization to access medical records that describe events captured in the endpoints
Who cannot join
- History of Autosomal Dominant Polycystic Kidney Disease
- Currently Active Systemic Lupus Erythematosus
- History of Hepatitis B Surface Antigen +
- History of Hepatitis C Antibody + being treated with antiviral therapy
- History of an organ transplant
- A planned renal transplant from a living donor during the study
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- History of hospitalization for congestive heart failure or pulmonary edema within 12 weeks before study randomization
- History of cirrhosis of the liver
- History of amyloidosis or light chain nephropathy
- History of hemoglobin A1c level > 11.0% (97 mmol/mol) within 12 weeks before study randomization
- History of recently active cardiovascular disease defined as:
- Unstable angina pectoris within 12 weeks before study randomization
- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before study randomization
- Cerebrovascular accident, including transient ischemic attack within 12 weeks before study randomization
- History of a diagnostic or interventional procedure that required intravenous administration of an iodinated contrast agent or gadolinium within 12 weeks before study randomization
- History of known severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy
- History of known 2o or 3o atrioventricular block not successfully treated with a pacemaker
- History or resuscitated sudden cardiac death
- History of an automatic implantable defibrillator
- QTc greater than 0.50 seconds on an ECG obtained during either Screen A or Screen B visits
- A serum magnesium level less than 1.4 meq/L on either Screen A or Screen B visit laboratory test results
- History of systemic immunosuppression for more than 15 days, cumulatively, within the 12 weeks prior to study randomization or anticipated need for more than 15 days of immunosuppression during the study
- Total bilirubin, aspartate transaminase (AST), or alanine transaminase (ALT) level greater than the upper limit of normal (ULN) or alkaline phosphatase level greater than two times the ULN on either the Screen A and Screen B visit laboratory test results
- Known hypersensitivity to any component of the study drug
- Current history of drug or alcohol abuse, as assessed by the investigator
- History of clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 12 weeks before study randomization
- In patients who have been on peritoneal dialysis for ≥ 6 months, two or more episodes of peritonitis in the 6 months before study randomization. In patients who have been on peritoneal dialysis for <6 months, one episode of peritonitis before study randomization
- History of a diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix
- History of a clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the patient while involved in the study
- Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
- Participation in a clinical study involving any intervention within 30 days prior to Screen A visit, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form
- Female patients who are pregnant, intend to become pregnant during this study, or are nursing
About this study
This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.
- Conditions
- End-Stage Renal Disease, Type 2 Diabetes Mellitus
- Being tested
- Bardoxolone Methyl 20 mg, Placebo
- Medical subject headings
- Kidney Failure, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bardoxolone Methyl 20 mgDrug
Oral, once daily
PlaceboDrug
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.
Number of Adverse Events
Measured: Approximately 17 months
Secondary outcomes (6)
Type of Adverse Events
Measured: Approximately 17 months
Change in Residual Renal Function
Measured: Baseline to 6 months
Maximum observed concentration
Measured: Day 0, 30, 60, 90, 120, 150, 180, 210
Time to maximum observed concentration
Measured: Day 0, 30, 60, 90, 120, 150, 180, 210
Area under the plasma concentration-time curve
Only the first 8 patients randomized will have the PK drawn and hours 2, 4, 8, and 24. All patients will have the PK drawn at 30, 60, 90, 120, 150 and 180 days.
Measured: 2, 4, 8, 24 hours, 30, 60, 90, 120, 150 and 180 days
Area under the curve
Only the first 8 patients randomized
Measured: 2, 4, 8 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study start31 Jul 2012
- Primary completion31 Oct 2012
- Study completion31 Oct 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.
- Other trials for End-Stage Renal DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576887
- Sponsor's protocol ID
- 402-C-1201
- Other IDs
- 2012-001563-78
- Status last verified
- May 2025
- First submitted
- 30 Mar 2012
- Last updated
- 29 May 2025
- Results posted
- 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 Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT01576887
- Acronym / sponsor ID
- 402-C-1201
- Conditions
- End-Stage Renal Disease, Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IDMC recommendation for safety concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2012 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Oct 2012 (actual)
- First posted
- 13 Apr 2012 (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 is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.
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 (11 listed)
- Patients must have ESRD and been on PD for longer than 3 months
- Patients must have had a diagnosis of T2DM prior to starting dialysis
- Patients must have RRF, as defined by the mean of urea and creatinine clearance on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 documented in the four months prior to the Screen A visit
- Patients must have RRF, as defined by the mean of urea and creatinine clearances on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 at both the Screen A and Screen B visits
- The RRF value obtained at the Screen B visit, must not be less than 50% of the RRF value obtained at the Screen A visit
Key exclusion criteria (32 listed)
- History of Autosomal Dominant Polycystic Kidney Disease
- Currently Active Systemic Lupus Erythematosus
- History of Hepatitis B Surface Antigen +
- History of Hepatitis C Antibody + being treated with antiviral therapy
- History of an organ transplant
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 20 mgOral, once daily | Drug | Bardoxolone Methyl |
| PlaceboOral, once daily | Drug | Placebo |
Primary outcome
Number of Adverse Events
Time frame: Approximately 17 months
6 secondary outcomes
Type of Adverse Events
Time frame: Approximately 17 months
Change in Residual Renal Function
Time frame: Baseline to 6 months
Maximum observed concentration
Time frame: Day 0, 30, 60, 90, 120, 150, 180, 210
Time to maximum observed concentration
Time frame: Day 0, 30, 60, 90, 120, 150, 180, 210
Area under the plasma concentration-time curve
Time frame: 2, 4, 8, 24 hours, 30, 60, 90, 120, 150 and 180 days
Area under the curve
Time frame: 2, 4, 8 and 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bardoxolone Methyl 20 mg in people with End-Stage Renal Disease and Type 2 Diabetes Mellitus, 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 11 inclusion and 32 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: withdrawn, 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of Adverse Events (time frame: Approximately 17 months). 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; AzTrials last refreshed its copy on 27 Oct 2026.