TerminatedPhase 3

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

Stopped: Discontinuation of all bardoxolone chronic kidney disease programs

United States270 participantsStarted 2019-03-08

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Not expected to reach end stage kidney disease (ESKD) or nephrotic syndrome within 12 weeks of study enrollment, in the investigator's judgement; subjects with eGFR \<20 ml/min/1.73m2 should be discussed with the medical monitor before enrollment (e.g., such subjects with an average rate of eGFR decline \> 1.0 ml/min/1.73m2 per month in the 3 months prior to eligibility assessment may not be eligible);
✓. BNP \< 200 pg/mL at the last on-treatment visit in the prior qualifying study or at a new screening visit, if applicable;
✓. No occurrence of a cardiovascular serious adverse event in the prior qualifying study or in the interval between the end of the qualifying study and the screening visit, if applicable.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From the first dose of the study drug (baseline) up to the end of the study follow-up (up to 4.2 years)

Trial details

NCT IDNCT03749447

SponsorBiogen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-23

Results submitted2024-02-20

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