Pharmacokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes

NCT01549769 | Terminated Phase 1

• 1 other identifier: 402-C-1102
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to evaluate the pharmacokinetics and pharmacodynamics of bardoxolone methyl in patients with chronic kidney disease and type 2 diabetes.

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Area under the curve

  24 hours

Secondary Outcomes (3)

• Time to maximum observed concentration

  56 days

• Area under the plasma concentration-time curve

  0 to last observed concentration

• Maximum observed concentration

  56 days

Study Arms (1)

Bardoxolone Methyl 20 mg

EXPERIMENTAL

Drug: Bardoxolone Methyl

Interventions

Bardoxolone Methyl DRUG

Oral, once daily

Bardoxolone Methyl 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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;

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Interventions

bardoxolone methyl

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: April 30, 2012
• Primary Completion: November 30, 2012
• Study Completion: October 31, 2013
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share