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An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE)

NCT03749447 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-06-03

Study results available
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Summary

This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with chronic kidney disease (CKD) who previously participated in one of the qualifying clinical studies with bardoxolone methyl. Patients will remain in the study until bardoxolone methyl is available through commercial channels or until patient withdrawal, whichever is sooner.

Conditions

  • Chronic Kidney Diseases
  • Alport Syndrome
  • Autosomal Dominant Polycystic Kidney

Interventions

DRUG

Bardoxolone methyl

Bardoxolone methyl capsules

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2023-08-23
Completion
2023-08-23
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Japan
  • Puerto Rico
  • Spain

Study Locations

More Related Trials

Entities

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 NCT03749447 on ClinicalTrials.gov