An Extended Access Program for Bardoxolone Methyl in Patients With CKD (EAGLE) (EAGLE)
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|ClinicalTrials.gov Identifier: NCT03749447|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : December 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Alport Syndrome Autosomal Dominant Polycystic Kidney||Drug: Bardoxolone methyl||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Extended Access Program to Assess Long Term Safety of Bardoxolone Methyl in Patients With Chronic Kidney Disease|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
Experimental: Bardoxolone methyl
The maximum dosage is determined by proteinuria status from the last on-treatment visit in the prior qualifying study or a screening visit, if necessary. Initial daily dose of bardoxolone methyl will dose-escalate at Week 2, Week 4, and Week 6.
Patients under the age of 18 will start dosing with bardoxolone methyl capsules every other day during Week 1 and daily at Week 2.
Patients will receive doses of bardoxolone methyl capsules in an escalating scheme from 5 mg up to no more than 30 mg.
Drug: Bardoxolone methyl
Bardoxolone methyl capsules
Other Name: RTA 402
- Long-term safety: by incidence of adverse events and serious adverse events [ Time Frame: Up to 5 years ]Long-term safety as measured by incidence of adverse events and serious adverse events during the study duration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749447
|Contact: Jeremy Davisfirstname.lastname@example.org|