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RTA 402

Phase 2

Diabetic Nephropathy | Small molecule | Nephrology |Biogen Inc.|Last Updated: May 29, 2025

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

RTA 402 · 1 trial · 1 indication

Phase 2 1
NCT00664027Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic NephropathyDiabetic Nephropathy
COMPLETED80 Analytics
PHASE2COMPLETED
Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic Nephropathy
Diabetic NephropathyUnlock trial analytics

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 to 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

Frequently asked questions about RTA 402

What is RTA 402 used for?

RTA 402 is an investigational small molecule being studied for the treatment of diabetic nephropathy, a kidney condition that can occur in people with diabetes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes RTA 402?

RTA 402 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with diabetic nephropathy.

What phase is RTA 402 in?

RTA 402 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The drug is being studied for its effects on renal function in patients with diabetic nephropathy.

What clinical trials is RTA 402 in?

RTA 402 has one completed clinical trial, identified as NCT00664027. This was a Phase IIa trial that enrolled 80 participants in the United States to determine the effects of bardoxolone methyl on renal function in patients with diabetic nephropathy. The trial was controlled but not double-blinded.

Is RTA 402 the same as bardoxolone methyl?

Yes, RTA 402 is also known as bardoxolone methyl. The clinical trial NCT00664027, which studied RTA 402, is titled 'Phase IIa Trial to Determine the Effects of Bardoxolone Methyl on Renal Function in Patients With Diabetic Nephropathy.'