Renal Insufficiency, ChronicPhase 1NCT01549769
Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
A Phase 1 study testing Bardoxolone Methyl in people with Renal Insufficiency, Chronic and Diabetes Mellitus, Type 2, run by Biogen.
Trial summary
This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2012to 31 Oct 2013
- Phase
- Phase 1
- 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 < 45.0 mL/min/1.73 m2.
- A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age (if diabetes developed at a younger age, a fasting C-peptide level must confirm type 2 diabetes);
- Male or female patients at least 18 years of age;
- Body mass index (BMI) between 18.5 and 45 kg/m2;
- Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 6 weeks prior to Study Day -1. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to Screening (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB, or taking an ACE inhibitor and/or ARB at levels below the goal dose set by K/DOQI guidelines (see Appendix B) must have a documented medical contraindication (e.g., hyperkalemia, hypotension), which the investigator must provide and discuss with a medical monitor prior to Study Day -1. 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;
- Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be ≤ 90 mmHg during screening;
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- Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) from screening through Study Day 84;
- Female patients of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment in the study;
- Willing and able to give written informed consent for study participation;
- Willing and able to cooperate with all aspects of the protocol;
Who cannot join
- Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a fasting C-peptide level must confirm type 2 diabetes;
- History of a renal transplant or a planned transplant from a living donor during the study;
- Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening;
- Acute dialysis or acute kidney injury within 24 weeks prior to Study Day -1;
- Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following Study Day -1, as assessed by the investigator;
- Albumin/creatinine ratio (ACR) > 3500 mg/g during screening;
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- Recently active cardiovascular disease defined as:
- Unstable angina pectoris within 12 weeks before Study Day -1;
- Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 12 weeks before Study Day -1;
- Cerebrovascular accident, including transient ischemic attack within 12 weeks before Study Day -1;
- Current diagnosis of Class III or IV NYHA congestive heart failure (Appendix C);
- Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy;
- Atrioventricular block, 2° or 3°, not successfully treated with a pacemaker;
- Diagnostic or interventional procedure that required a contrast agent that may induce nephropathy within 30 days prior to Study Day -1, or planned during the study;
- Systemic immunosuppression for more than 15 days , cumulatively, within the 12 weeks prior to Study Day -1, or anticipated need for 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 ANY screening laboratory test result;
- Iron saturation < 20% on Study Day -1. If iron saturation is < 20% at screening, iron supplements may be provided prior to Study Day -3;
- Serum magnesium levels < 1.3 mEg/L (0.65 mmol/L) on Study Day -1. If serum magnesium levels are < 1.3 mEg/L (0.65 mmol/L) at screening, oral magnesium replacement may be provided prior to Study Day -3;
- 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 prior to Study Day -1;
- Donation or receipt of blood or blood components within the 4 weeks prior to Study Day -1. The investigator should instruct patients who participate in this study not to donate blood or blood components for 4 weeks after the completion of the study;
- Abnormal ECG at screening, which is interpreted by the investigator to be clinically significant;
- Use of tobacco-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) or products for smoking cessation 2 weeks prior to Study Day -1;
- Treated with any investigational agent within 30 days before Study Day -1, 5 half-lives, or twice the duration of biological effect of the previous investigational drug (whichever is longer);
- 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 Study Day -1, 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: A Multiple-Dose, Open-Label Pharmakokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in patients with chronic kidney disease and type 2 diabetes.
- Being tested
- Bardoxolone Methyl
- Medical subject headings
- Renal Insufficiency, 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 MethylDrug
Oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Bardoxolone Methyl 20 mg | Experimental | Not described Receives: Drug: Bardoxolone Methyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Measured: 24 hours
Secondary outcomes (3)
Time to maximum observed concentration
Measured: 56 days
Area under the plasma concentration-time curve
Measured: 0 to last observed concentration
Maximum observed concentration
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study start30 Apr 2012
- Primary completion30 Nov 2012
- Study completion31 Oct 2013
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 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549769
- Sponsor's protocol ID
- 402-C-1102
- Status last verified
- May 2025
- First submitted
- 6 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 Multiple-Dose, Open-Label Pharmakokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01549769
- Acronym / sponsor ID
- 402-C-1102
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDMC recommendation for safety concerns
- Enrolment
- 24 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 30 Nov 2012 (actual)
- Study completion
- 31 Oct 2013 (actual)
- First posted
- 9 Mar 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 to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in patients with chronic kidney disease and type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bardoxolone Methyl 20 mg | Experimental | Drug: Bardoxolone Methyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Screening eGFR ≥ 15.0 and < 45.0 mL/min/1.73 m2.
- A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age (if diabetes developed at a younger age, a fasting C-peptide level must confirm type 2 diabetes);
- Male or female patients at least 18 years of age;
- Body mass index (BMI) between 18.5 and 45 kg/m2;
- Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) for at least 6 weeks prior to Study Day -1. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to Screening (i.e., no change in dosage or medication). Patients not taking an ACE inhibitor and/or ARB, or taking an ACE inhibitor and/or ARB at levels below the goal dose set by K/DOQI guidelines (see Appendix B) must have a documented medical contraindication (e.g., hyperkalemia, hypotension), which the investigator must provide and discuss with a medical monitor prior to Study Day -1. 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;
Key exclusion criteria (28 listed)
- Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a fasting C-peptide level must confirm type 2 diabetes;
- History of a renal transplant or a planned transplant from a living donor during the study;
- Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening;
- Acute dialysis or acute kidney injury within 24 weeks prior to Study Day -1;
- Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following Study Day -1, as assessed by the investigator;
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 MethylOral, once daily | Drug | Bardoxolone Methyl 20 mg |
Primary outcome
Area under the curve
Time frame: 24 hours
3 secondary outcomes
Time to maximum observed concentration
Time frame: 56 days
Area under the plasma concentration-time curve
Time frame: 0 to last observed concentration
Maximum observed concentration
Time frame: 56 days
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.
- 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 1 study testing Bardoxolone Methyl 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 10 inclusion and 28 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Area under the curve (time frame: 24 hours). 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.