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RTA 402 in CKD with Type 2 Diabetes
NCT01574365Phase 2
Key facts
- Status
- Terminated
- Start
- Feb 2012
- Primary completion
- Nov 2013
- Countries
- 1
- Sponsor
- Kyowa Kirin
- Modality
- Classical Binding Small Molecules
- Drugs
- bardoxolone methyl
- Conditions
- chronic kidney disease (CKD)
01
Overview
Phase 2, randomised, open-label trial of bardoxolone methyl in chronic kidney disease (CKD) (4 arms), sponsored by Kyowa Kirin. Primary endpoints: Changes in eGFR up to 16 weeks and Adverse event collection and assessment up to 16 weeks. Started Feb 2012; status: terminated.
02
Design
4 arms- Study design
- RandomizedOpen-label
RTA402
RTA 402 (Dose 1)
RTA402 Low
RTA 402 Low Dose
RTA402 Medium-low
RTA 402 Medium-low Dose
RTA402 Medium-high
RTA 402 Medium-high Dose
03
Who it enrols
Patients with CKD and Type 2 Diabetes Mellitus, treated with stable dose of ACE inhibitors and/or ARB. Excludes Type 1 diabetes, non-diabetic renal disease, renal transplantation, uncontrolled hypertension, and HbA1c > 10%.
04
Endpoints
Primary
Changes in eGFR
Adverse event collection and assessment
Secondary
Profile of Pharmacokinetics
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