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RTA 402

Phase 2

Diabetic Nephropathy | Small molecule | Other |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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00664027Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic NephropathyPHASE2 COMPLETED 80 — — Apr 30, 2008May 31, 2009May 29, 20253 United States
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Study Endpoints
Primary Endpoints
To determine the effects of RTA 402 administered orally at three dose strengths on the glomerular filtration rate (as estimated by the MDRD formula) in patients with diabetic nephropathy (stratum 1).
28 days
To determine the effects of RTA 402 on glomerular filtration rate (as estimated by the MDRD formula) when administered for 28 days at dose of 25 mg followed by a dose of 75 mg for another 28 days in patients with diabetic nephropathy (stratum 2).
56 days
Secondary Endpoints
To evaluate the safety and tolerability of oral RTA 402 administered orally at three dose strengths in patients with diabetic nephropathy.
28 days
To evaluate the effects of RTA 402 on the serum creatinine level, iohexol serum clearance (one study center only), creatinine clearance, and urine albumin/creatinine ratio in patients with diabetic nephropathy.
28 days (stratum 1), 56 days (stratum 2)
To evaluate the effects of RTA 402 on hemoglobin A1c in all patients enrolled and on insulin response by the hyperinsulinemic euglycemic clamp test in patients enrolled at only one of the study centers.
28 days (stratum 1), 56 days (stratum 2)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
25 mgEXPERIMENTAL25 mg RTA 402 (Bardoxolone methyl)/Stratum 1
75 mgEXPERIMENTAL75 mg RTA 402 (Bardoxolone methyl)/Stratum 1
150 mgEXPERIMENTAL150 mg RTA 402 (Bardoxolone methyl)/Stratum 1
25/75 mgEXPERIMENTAL25 mg -\> 75 mg RTA 402 (Bardoxolone methyl)/Stratum 2
Interventions
NameTypeDescription
RTA 402 (Bardoxolone Methyl)DRUGStratum 1: 25, 75, 150mg/day, orally, 28 consecutive days Stratum 2: 25 mg/day, orally, 28 consecutive days followed by 75 mg/day, orally, 28 consecutive days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Diagnosis of type 2 diabetes; 2. Serum creatinine in women 1.3 - 3.0 mg/dL (115-265 μmol/L), inclusive, and in men 1.5 - 3.0 mg/dL (133-265 μmol/L), inclusive; 3. Patient must agree to practice effective contraception. 4. Patient must have a negative urine pregnancy test with...

Countries:United States
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Competitive Landscape -Diabetic Nephropathy 8 trials
CompanyTickerTrialsLead PhaseDrugs
Regeneron Pharmaceuticals, Inc.REGN1PHASE2ALN-ANG3, Evinacumab
DexCom, Inc.DXCM1PHASE3Sotagliflozin
Novartis AG Sponsored ADRNVS1PHASE2Atrasentan
ProKidney Corp. Class APROK2 — Renal Autologous Cell Therapy
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