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The Phase II Study of Bardoxolone Methyl in Patients with Chronic Kidney Disease and Type 2 Diabetes; TSUBAKI Study

RTA 402 Phase 2 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients with Chronic Kidney Disease and Type 2 Diabetes)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222666
Enrollment
Unknown
Registered
2014-11-25
Start date
2014-11-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CKD patients with type 2 diabetes

Interventions

investigational material(s) Generic name etc : RTA 402 INN of investigational material : Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigational mate

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -CKD patients with type 2 diabetes mellitus -Patients whose eGFR levels are eligible for this study -Patients being treated with stable dose of ACE inhibitors and/or ARB etc.

Exclusion criteria

Exclusion criteria: -Patients with type 1 diabetes mellitus -Patients with known non-diabetic renal disease -Patients with a history of renal transplantation -Patients with mean SBP > 160 mmHg or DBP > 90 mmHg -Patients with HbA1c > 10% -Patients with cardiovascular disease specified in the study protocol etc.

Design outcomes

Primary

MeasureTime frame
Safety aderse events Efficacy Changes in GFR from baseline to week 16—

Secondary

MeasureTime frame
Efficacy Change in eGFR from baseline to week 16 Pharmacokinetics Plasma level of RTA 402—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026