A Double-Blind, Randomized, Placebo-Controlled Safety Study Evaluating the Effects of Residual Renal Function (RFF) in Patients With End-Stage Renal Disease and Type 2 Diabetes Mellitus on Peritoneal Dialysis

NCT01576887 | Withdrawn Phase 2

• 2 other identifiers: 402-C-12012012-001563-78
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multi-center, double-blinded, randomized, study of bardoxolone methyl treatment in patients with End-Stage Renal Disease (ERSD) and Type 2 Diabetes Mellitus (T2DM) on peritoneal dialysis.

Conditions

End-Stage Renal Disease; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Approximately 17 months

Secondary Outcomes (6)

• Type of Adverse Events

  Approximately 17 months

• Change in Residual Renal Function

  Baseline to 6 months

• Maximum observed concentration

  Day 0, 30, 60, 90, 120, 150, 180, 210

• Time to maximum observed concentration

  Day 0, 30, 60, 90, 120, 150, 180, 210

• Area under the plasma concentration-time curve

  2, 4, 8, 24 hours, 30, 60, 90, 120, 150 and 180 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Bardoxolone Methyl

EXPERIMENTAL

Drug: Bardoxolone Methyl 20 mg

Interventions

Bardoxolone Methyl 20 mg DRUG

Oral, once daily

Bardoxolone Methyl

Placebo DRUG

Oral, once daily

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients must have ESRD and been on PD for longer than 3 months
• Patients must have had a diagnosis of T2DM prior to starting dialysis
• Patients must have RRF, as defined by the mean of urea and creatinine clearance on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 documented in the four months prior to the Screen A visit
• Patients must have RRF, as defined by the mean of urea and creatinine clearances on a 24 hour urine collection, ≥ 25 Liters/week/1.73 m2 at both the Screen A and Screen B visits
• The RRF value obtained at the Screen B visit, must not be less than 50% of the RRF value obtained at the Screen A visit
• Patients must be at least 18 years of age
• Patients must have a mean systolic blood pressure (SBP) on three readings at both Screen A and Screen B visits ≤ 160 mmHg and ≥ 90 mmHg
• Patients must have a mean diastolic blood pressure (DBP) on three readings at both Screen A and Screen B visits \< 100 mmHg and ≥ 40 mmHg
• Patients must be 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
• Patients must be willing and able to cooperate with all aspects of the protocol
• Patients must be willing and able to give written informed consent to participate in the study. They must provide consent for access to medical data according to appropriate local data protection legislation and allow authorization to access medical records that describe events captured in the endpoints

You may not qualify if:

• History of Autosomal Dominant Polycystic Kidney Disease
• Currently Active Systemic Lupus Erythematosus
• History of Hepatitis B Surface Antigen +
• History of Hepatitis C Antibody + being treated with antiviral therapy
• History of an organ transplant
• A planned renal transplant from a living donor during the study
• History of hospitalization for congestive heart failure or pulmonary edema within 12 weeks before study randomization
• History of cirrhosis of the liver
• History of amyloidosis or light chain nephropathy
• History of hemoglobin A1c level \> 11.0% (97 mmol/mol) within 12 weeks before study randomization
• History of 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
• History of a diagnostic or interventional procedure that required intravenous administration of an iodinated contrast agent or gadolinium within 12 weeks before study randomization

Sponsors & Collaborators

• Biogen: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus, Type 2

Interventions

bardoxolone methyl

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 13, 2012
• Study Start: July 31, 2012
• Primary Completion: October 31, 2012
• Study Completion: October 31, 2012
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share