Chronic Kidney DiseasePhase 1NCT01500798
A Pharmacodynamic Study of Measured Glomerular Filtration Rate in Patients With Chronic Kidney Disease and Type 2 Diabetes
A Phase 1 study testing 20 mg bardoxolone methyl in people with Chronic Kidney Disease and Type 2 Diabetes, run by Biogen.
Trial summary
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Type 2 Diabetes
- What is being tested?
- 20 mg bardoxolone methyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2012to 1 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 ≥ 30.0 and < 60.0 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 be ≥ 0.1 ng/mL to confirm type 2 diabetes);
- Male or female patients 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 Screening Visit and during screening. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to Screening Visit A and during 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 3) should have a documented medical contraindication (e.g., hyperkalemia, dry cough, angioedema), which the investigator must discuss with the appropriate medical monitor;
- Albumin/creatinine ratio (ACR) < 300 mg/g;
- Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be < 90 mmHg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within the described range;
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- Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential, [see Section 9.7]) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested;
- 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 that 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., known polycystic kidney disease or family history of a hereditary form of kidney disease) [nephrosclerosis superimposed on diabetic kidney disease is acceptable];
- Ongoing clinical investigation with evidence (e.g., unexplained hematuria or red blood cell or white blood cell casts) suggesting non-diabetic renal disease other than nephrosclerosis;
- History of a renal donation, transplant or a planned transplant from a living donor during the study;
- Hemoglobin A1c level > 9.0% (75 mmol/mol) during screening;
- Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening;
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- 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:
- 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;
- Current diagnosis of Class III or IV NYHA congestive heart failure (Appendix 4);
- Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy;
- Atrioventricular block, 2o or 3o, not successfully treated with a pacemaker;
- Diagnostic or interventional procedure that required a contrast agent within 30 days prior to baseline mGFR visit 1 or planned during the study;
- Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization 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;
- Female patients who are pregnant, intend to become pregnant during the study, or are nursing;
- BMI < 18.5 kg/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 prior to Screening Visit or during screening;
- Diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
- A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the patient while involved in the study;
- 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 randomization, concurrent participation in such a study, or participation in a prior clinical study involving bardoxolone methyl in any form.
About this study
Official title: A Pharmacodynamic Study of Measured Glomerular Filtration Rate Assessed by Tc99m-DTPA in Patients With Chronic Kidney Disease and Type 2 Diabetes
This is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints.
Read the detailed description
This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Being tested
- 20 mg bardoxolone methyl, Placebo
- 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.
20 mg bardoxolone methylDrug
20 mg, 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: 20 mg bardoxolone methyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured GFR assessed by plasma clearance of Tc99m-DTPA
Measured GFR assessed by plasma clearance of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20
Measured: 24 weeks
Secondary outcomes (2)
Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA
Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20
Measured: 24 weeks
Circulating endothelial cell assessments
Circulating endothelial cell assessments at Baseline mGFR assessment 1 and at Weeks 8 and 20
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start31 Jan 2012
- Primary completion1 Nov 2012
- Study completion1 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 Chronic Kidney 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500798
- Sponsor's protocol ID
- 402-C-1005
- Status last verified
- Oct 2023
- First submitted
- 22 Dec 2011
- Last updated
- 27 Oct 2023
- 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 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic Study of Measured Glomerular Filtration Rate Assessed by Tc99m-DTPA in Patients With Chronic Kidney Disease and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01500798
- Acronym / sponsor ID
- 402-C-1005
- Conditions
- Chronic Kidney Disease, Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDMC recommendation for safety concerns
- Enrolment
- 18 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2012 (actual)
- Primary completion
- 1 Nov 2012 (actual)
- Study completion
- 1 Oct 2013 (actual)
- First posted
- 28 Dec 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 is a 24-week multi-center, double-blind, randomized, exploratory study of bardoxolone methyl treatment in 18 patients with Stage 3 CKD (eGFR greater than or equal to 30.0 to less than 60.0 ml/min/1.73m2) and diabetes to ensure at least 15 patients complete the study for evaluation of the primary endpoints.
Detailed description
This study was previously posted by Reata Pharmaceuticals. In September 2023, sponsorship of the trial was transferred to Biogen.
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: 20 mg bardoxolone methyl |
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 ≥ 30.0 and < 60.0 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 be ≥ 0.1 ng/mL to confirm type 2 diabetes);
- Male or female patients 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 Screening Visit and during screening. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to Screening Visit A and during 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 3) should have a documented medical contraindication (e.g., hyperkalemia, dry cough, angioedema), which the investigator must discuss with the appropriate medical monitor;
- Albumin/creatinine ratio (ACR) < 300 mg/g;
Key exclusion criteria (26 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., known polycystic kidney disease or family history of a hereditary form of kidney disease) [nephrosclerosis superimposed on diabetic kidney disease is acceptable];
- Ongoing clinical investigation with evidence (e.g., unexplained hematuria or red blood cell or white blood cell casts) suggesting non-diabetic renal disease other than nephrosclerosis;
- History of a renal donation, transplant or a planned transplant from a living donor during the study;
- Hemoglobin A1c level > 9.0% (75 mmol/mol) during 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 |
|---|---|---|
| 20 mg bardoxolone methyl20 mg, oral, once daily | Drug | Bardoxolone methyl |
| PlaceboOral, once daily | Drug | Placebo |
Primary outcome
Measured GFR assessed by plasma clearance of Tc99m-DTPA
Time frame: 24 weeks
Measured GFR assessed by plasma clearance of Tc99m-DTPA at Baseline mGFR assessment 1, Baseline mGFR assessment 2, and at Weeks 8, 16 and 20
2 secondary outcomes
Measured GFR assessed by gama camera assessment of renal uptake of Tc99m-DTPA
Time frame: 24 weeks
Circulating endothelial cell assessments
Time frame: 24 weeks
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 27 Oct 2023.
- 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 20 mg bardoxolone methyl in people with Chronic Kidney Disease and Type 2 Diabetes, 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 26 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 27 Oct 2023. 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 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?
Measured GFR assessed by plasma clearance of Tc99m-DTPA (time frame: 24 weeks). 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 27 Oct 2023.