drugset / Trial / NCT03749447

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

NCT03749447 ↗

Phase 3 Terminated 270 enrolled Biogen
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-03-08
Primary completion
2023-08-23
Completion
2023-08-23

Outcome

Outcome not reported

Stopped: “Discontinuation of all bardoxolone chronic kidney disease programs”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bardoxolone methyl Small molecule 30 mg —