Chronic Kidney Disease Stage 4 MedDRA version: 14.1 Level: SOC Classification code 10038359 Term: Renal and urinary disorders System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Bardoxolone methyl
Product Code: RTA-402
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: bardoxolone methyl
CAS Number: 218600-53-4
Current Sponsor code: RTA 402
Other descript
Sponsors
Reata Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Screening eGFR = 15.0 and =65 years) yes F.1.3.1 Number of subjects for this age range 640
Exclusion criteria
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., known polycystic kidney disease or family history of a hereditary form of kidney disease) [nephrosclerosis superimposed on diabetic kidney disease is acceptable]; 3. 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; 4. History of a renal transplant or a planned transplant from a living donor during the study; 5. Albumin to creatinine ratio (ACR) at Screening Visit B greater than 3500 mg/g; 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: • 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 B); 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. Diagnostic or interventional procedure that required a contrast agent within 30 days prior to study randomization or planned during the study; 13. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study; 14. 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; 15. Female patients who are pregnant, intend to become pregnant during the study, or are nursing; 16. BMI < 18.5 kg/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 prior to Screening Visit A or during screening; 20. Diagnosis or treatment of a malignancy in the past 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular death in patients with Stage 4 CKD and type 2 diabetes receiving standard of care;Secondary Objective: To assess the safety of bardoxolone methyl relative to placebo in patients with Stage 4 CKD and type 2 diabetes receiving standard of care;Primary end point(s): Time to first event of the composite endpoint consisting of: • ESRD (need for chronic dialysis or renal transplantation) • Cardiovascular death ;Timepoint(s) of evaluation of this end point: Throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Rate of change in eGFR over the duration of study 2. Tme to first hospitalization for heart failure 3. Tme to first event of the composite endpoint consisting of: • Non-fatal myocardial infarction • Non-fatal stroke • Hospitalization for heart failure • Cardiovascular death;Timepoint(s) of evaluation of this end point: Throughout the trial | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Mexico, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactClinical Trials Helpdesk
Abbott Laboratories
Outcome results
None listed