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Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes (BEACON)

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ClinicalTrials.gov Identifier: NCT01351675
Recruitment Status : Terminated (IDMC recommendation for safety concerns)
First Posted : May 11, 2011
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE May 11, 2011
Last Update Posted Date May 14, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
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 chroinic dialysis or renal transplantation)
  • Cardiovascular death
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
  • 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 ]
    Time-to-first event in the composite cardiorenal endpoint defined as:
    • Cardiovascular death
    • Non-fatal myocardial infarction
    • Non-fatal stroke
    • Hospitalization for heart failure
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
  • Rate of change in 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 ]
    Time-to-first event in the composite cardiorenal endpoint defined as:
    • Cardiovascular death
    • Non-fatal myocardial infarction
    • Non-fatal stroke
    • Hospitalization for heart failure
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes
Official Title  ICMJE Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes: the Occurrence of Renal Events (BEACON)
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Insufficiency, Chronic
  • Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo
    Oral, once daily
  • Drug: Bardoxolone Methyl: 20 mg
    20 mg, oral, once daily
    Other Name: RTA-402
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Bardoxolone Methyl
    Intervention: Drug: Bardoxolone Methyl: 20 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 18, 2012)
2185
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2011)
1600
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Screening eGFR ≥ 15.0 and < 30.0 mL/min/1.73 m2;
  2. A history of type 2 diabetes; diagnosis should have been made at ≥ 30 years of age;
  3. Male or female at least 18 years of age;
  4. 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;
  5. 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);
  6. 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;
  7. 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);
  8. Willing and able to cooperate with all aspects of the protocol;
  9. 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

Exclusion Criteria:

  1. Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a C-peptide level must confirm type 2 diabetes;
  2. Known non-diabetic renal disease (e.g., polycystic kidney disease, focal segmental glomerulosclerosis) [nephrosclerosis superimposed on diabetic kidney disease is acceptable];
  3. Ongoing clinical evidence suggesting non-diabetic renal disease other than nephrosclerosis;
  4. History of a renal transplant or a planned transplant from a living donor during the study;
  5. Albumin to creatinine ratio (ACR) greater than 3500 mg/g (395.5 mg/mmol);
  6. Hemoglobin A1c level > 11.0% (97 mmol/mol) during screening;
  7. Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening;
  8. Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 12 weeks following randomization, as assessed by the investigator;
  9. 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;
  10. Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy;
  11. Atrioventricular block, 2o or 3o, not successfully treated with a pacemaker;
  12. DAdministration of a contrast agent that may induce nephropathy within 30 days prior to study randomization or planned during the study;
  13. Systemic immunosuppression for a total of > 2 weeks, cumulatively, within the 12 weeks prior to randomization or planned during the study;
  14. 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;
  15. Female patients who are pregnant, intend to become pregnant during the study, or are nursing;
  16. BMI < 18.5 g/m2
  17. Known hypersensitivity to any component of the study drug;
  18. Current history of drug or alcohol abuse as assessed by the investigator;
  19. Clinically significant infection requiring intravenous administration of antibiotics or hospitalization within 6 weeks of screening or during screening;
  20. Hepatitis B surface antigen positive;
  21. 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;
  22. A clinical condition that in the judgment of the investigator could potentially pose a health risk to the patient while involved in the study;
  23. 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;
  24. Unable to communicate or cooperate with the investigator due to language problems, poor mental development or impaired cerebral function.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Israel,   Italy,   Mexico,   Puerto Rico,   Spain,   Sweden,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01351675
Other Study ID Numbers  ICMJE 402-C-0903
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Reata Pharmaceuticals, Inc.
Study Sponsor  ICMJE Reata Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Reata Pharmaceuticals, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP