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

A Multiple-Dose, Open-Label Pharmakokinetic and Pharmacodynamic Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes

NCT01549769•Biogen

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Screening eGFR ≥ 15.0 and \< 45.0 mL/min/1.73 m2.
•2. 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);
•3. Male or female patients at least 18 years of age;
•4. Body mass index (BMI) between 18.5 and 45 kg/m2;
•5. 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;
•6. Mean systolic blood pressure (SBP) must be ≤ 160 mmHg and ≥ 105 mmHg and mean diastolic blood pressure (DBP) must be ≤ 90 mmHg during screening;
•7. 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;
•8. 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;
•9. Willing and able to give written informed consent for study participation;
•10. Willing and able to cooperate with all aspects of the protocol;

Exclusion Criteria

•1. Type 1 diabetes mellitus (juvenile onset). If a history of diabetic ketoacidosis exists, a fasting C-peptide level must confirm type 2 diabetes;
•2. History of a renal transplant or a planned transplant from a living donor during the study;
•3. Hemoglobin A1c level \> 11.0% (97 mmol/mol) during screening;
•4. Acute dialysis or acute kidney injury within 24 weeks prior to Study Day -1;
•5. 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;
•6. Albumin/creatinine ratio (ACR) \> 3500 mg/g during screening;
•7. 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;
+18 more criteria

Key Dates

Start Date

April 30, 2012

Primary Completion Date

November 30, 2012

Completion Date

October 31, 2013

Last Updated

May 29, 2025

Enrollment

ACTUAL participants

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2

Interventions

Bardoxolone Methyl

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

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