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Bardoxolone Methyl

Phase 2

Chronic Kidney Disease | Small molecule | Metabolic |Biogen Inc.|Last Updated: May 29, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment227
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00811889Trial to Determine the Effects of Bardoxolone Methyl on eGFR in Patients With Type 2 Diabetes and Chronic Kidney DiseasePHASE2 COMPLETED 227Apr 30, 2009Dec 31, 2010May 29, 202542 United States
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Study Endpoints
Primary Endpoints
To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 6 months (24 weeks) following randomization
6 months (24 weeks)
To determine the safety and tolerability of bardoxolone methyl when administered for 12 months (52 weeks)following randomization to type 2 diabetic patients with CKD (eGFR 20 - 45 mL/min/1.73m2).
1 year (52 weeks)
Secondary Endpoints
To quantify the effects of bardoxolone methyl at two different dosing levels relative to placebo on: Hemoglobin A1c, Serum Creatinine, Urine, Intact PTH albumin/creatinine ratio, Serum Phosphorus, Blood Urea Nitrogen, Uric Acid
6 months (24 weeks) and 1 year (52 weeks)
To determine the change in eGFR from baseline in patients with type 2 diabetes and CKD (baseline eGFR = 20 - 45 mL/min/1.73m2) after receiving bardoxolone methyl for 12 months (52 weeks) following randomization.
12 months (52 weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
Bardoxolone Methyl (RTA 402): 75mgEXPERIMENTAL -
Bardoxolone Methyl (RTA 402): 150mgEXPERIMENTAL -
Bardoxolone Methyl (RTA 402): 25mgEXPERIMENTAL -
Interventions
NameTypeDescription
PlaceboOTHERPlacebo
Bardoxolone Methyl (RTA 402)DRUGOral, Once Daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: 1. Male or female patient, at least 18 years of age with known type 2 diabetes, diagnosis of type 2 diabetes should have been made at \> 30 years of age (if diabetes developed at a younger age, C-peptide level may be obtained to confirm diagnosis) 2. The average of two eGFR valu...

Countries:United States
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