MedTrace Logo

Bardoxolone Methyl Evaluation in Patients With Chronic Kidney Disease and Type 2 Diabetes

NCT01351675 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2185

Last updated 2025-05-29

No results posted yet for this study

Summary

This study assesses the efficacy of bardoxolone methyl relative to placebo in delaying progression to end-stage renal disease (ESRD) and cardiovascular deaths in patients with Stage 4 Chronic Kidney Disease (CKD) and type 2 diabetes receiving standard of care.

Conditions

  • Renal Insufficiency, Chronic
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Placebo

Oral, once daily

DRUG

Bardoxolone Methyl: 20 mg

20 mg, oral, once daily

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-10-31
Completion
2012-12-31

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01351675 on ClinicalTrials.gov