Pilot Assessment of the Effects of Bardoxolone Methyl on Renal Perfusion, Systemic Haemodynamics and Cardiac Function in Patients With Chronic Kidney Disease and Type 2 Diabetes

NCT01551446 | Withdrawn Phase 1

• 1 other identifier: 402-C-1103
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to evaluate the variability of several pharmacodynamic measures of kidney function, cardiovascular function, cerebral perfusion, and haemodynamics.

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in renal perfusion

  The change in renal perfusion measured by ASL-MRI Scanning

  20 weeks

Secondary Outcomes (9)

• Change in cardiac function

  20 weeks

• Change in cerebral perfusion

  20 weeks

• Change in haemodynamic variables

  20 weeks

• Change in arterial stiffness

  20 weeks

• Change in body composition

  20 weeks

Study Arms (1)

Bardoxolone Methyl 20mg

EXPERIMENTAL

Drug: Bardoxolone Methyl

Interventions

Bardoxolone Methyl DRUG

Oral, once daily

Bardoxolone Methyl 20mg

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 ≤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 Study Day 1. The dosage of ACE inhibitor and/or ARB must be stable for 2 weeks prior to and/or 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 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 Study Day 1;
• Mean systolic blood pressure (SBP) ≤160 mmHg and ≥105 mmHg and mean diastolic blood pressure (DBP) ≤90 mmHg during screening; both mean SBP and mean DBP (determined as the average of three readings) must be within the described range during the screening period;
• Willing to practice methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) during screening, while taking study drug and for at least 30 days after the last dose of study drug is ingested;
• Serum magnesium level must be ≥1.3 mEq/L (0.65 mmol/L) during the screening period;
• Willing and able to cooperate with all aspects of the protocol;
• Willing to and able to give written informed consent for study participation.

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;
• Known non-diabetic renal disease (e.g., known polycystic kidney disease, family history of a hereditary form of kidney disease, or congenital absence of one kidney) \[nephrosclerosis superimposed on diabetic kidney disease is acceptable\];
• 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;
• Albumin/creatinine (ACR) during screening period greater than 3500 mg/g (395.5 mg/mmol);
• Hemoglobin A1c level \>11.0% (97 mmol/mol) during screening period;
• Acute dialysis or acute kidney injury within 12 weeks prior to screening or during screening;
• Clinical signs and/or symptoms of uremia and expected need for renal replacement therapy within 6 weeks following Study Day 1, as assessed by the investigator;
• 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;
• Clinical diagnosis of severe obstructive valvular heart disease or severe obstructive hypertrophic cardiomyopathy;
• Atrioventricular block, 2o or 3o;
• Administration of a contrast agent that may induce nephropathy within 30 days prior to Study Day 1 or planned 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 5, 2012
• First Posted: March 12, 2012
• Study Start: April 30, 2012
• Primary Completion: November 30, 2012
• Study Completion: November 30, 2012
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share